BARD 0112680Recalls & reported problems

Summary

The FDA's MAUDE database contains 494 adverse event reports that list this exact device (DI 00801741016530), received between Nov 14, 2013 and Sep 30, 2026 — classified as 1 death, 480 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Defective Device” (429 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 494 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2005 - Patient was diagnosed with large right inguinal hernia thereby underwent open repair with implant of Composix Kugel Mesh (Device 1), synthetic mesh and Bard Flat Mesh (Device 2). Per op notes, "A right transvers incision was made. The hernia was identified and reduced. The huge direct sac was returned to its subfascial position and the indirect sac was also dissected and freed. A large Composix Kugel Mesh (Device 1) was placed through the floor of the inguinal canal and secured to Cooper¿s ligament. A second large synthetic mesh was placed through the internal ring and secured the wound subfascial portion onto the Composix Kugel Mesh (Device 1). A large piece of Bard Flat Mesh (Device 2) was placed on the entire floor of the inguinal canal and secured to the fascia at the pubic tubercle. The fascia was then closed with suture."(b)(6)2006 - Patient was diagnosed with right scrotal hematoma thereby underwent open repair with incision and drainage of hematoma. Per op notes, "An incision was made in the upper scrotum. A large amount of serous fluid was removed and the wound was irrigated, removed some of the organized fibrous material. Drain was th

  Patient problems: Fibrosis; Hematoma; Impaired Healing; Inflammation; Unspecified Infection

  MAUDE report 50949396 ↗
• InjurySep 29, 2026Patient-Device Incompatibility

  Patient problems: Hernia

  MAUDE report 50929895 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6)2015 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1), Bard Flat Mesh (Device 2). Per op notes, "A direct inguinal hernia was identified and dissected. The direct component was reduced and PerFix Plug (Device 1) was secured to the area of deep inguinal ring, the patch was secured to pubic tubercle." On (b)(6)2018 - Patient was diagnosed with chronic left groin pain, thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 3). Per op notes, "A moderate hiatal hernia was identified. There was no recurrent left inguinal hernia. The previously placed plug (Device 1) was found compressing on spermatic structures. A 3DMax Mesh (Device 3) was placed in the left groin area and was sutured. The old scar in the left groin was noted. Extensive adhesions between the mesh and the external oblique, conjoined tendon, spermatic vessels, vas deferens were noted. The PerFix Plug (Device 1) and Bard Flat Mesh (Device 2) was excised."

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 50797644 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2006- Patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of Composix Kugel Mesh (Device 1). Per op notes, "Hernia sac in abdominal region was identified and was dissected. A Composix Kugel Mesh (Device 1) was then placed o er the fascial defect and sutured."(b)(6) 2006 - Patient was diagnosed with ventral incisional hernia thereby underwent open repair with explant of Composix Kugel Mesh (Device 1), implant of Composix Kugel Mesh (Device 2). Per op notes, "The previous midline scar tissue was excised. The hernia sac was identified and excised. The previously placed mesh (Device 1) in the colostomy site was noted and was found bunched up and covered with adhesions sand the mesh (Device 1) was removed. A large sized Composix Kugel Mesh (Device 2) was then placed in the abdominal region and was sutured." (b)(6) 2010 - Patient was diagnosed with incisional hernia, left sided pain, thereby underwent open repair with implant of synthetic mesh. Per op notes, "The old scar was dissected. Hernia sac in left upper quadrant was identified and was dissected. A synthetic mesh was placed and sutured. In the right upper

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 50459844 ↗
• InjuryAug 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2012 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two Bard Flat Mesh (Device 1 - left and 2 - right). Per op notes, "An incision over the left inguinal canal, a Bard Flat Mesh (Device 1 - left) was placed using sutures. An incision over the right inguinal canal, a Bard Flat Mesh (Device 2 - right) was placed using sutures."(b)(6) 2013 - Patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two 3DMax Mesh (Device 3 - left and 4 - right). Per op notes, "Attention to the left first, a 3DMax Mesh (Device 3 - left) was placed to the cooper's ligament using tacks. Then attention to the right side, a 3DMax Mesh (Device 4 - right) was placed to the cooper's ligament using tacks."(b)(6) 2015 - Patient was diagnosed with recurrent left inguinal hernia thereby underwent repair. Per op notes, "An incision to the left inguinal canal, the previously placed mesh (Device 1 and 3) was seen which is lateral to the pubic tubercle. An unknown was placed to the pubic tubercle using prolene sutures."

  Patient problems: Hernia

  MAUDE report 50434991 ↗
• InjuryJun 23, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA X 2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH. PER OP NOTES, "A PERIUMBILICAL INCISION WAS MADE. THE HERNIA SAC WAS IDENTIFIED AND REDUCED. THE EXCESS SAC WAS EXCISED. A PIECE OF BARD FLAT MESH (DEVICE 1) WAS PLACED IN THE PLANE BETWEEN THE PERITONEUM AND FASCIA AND SECURED IN PLACE WITH SUTURES. ANOTHER INCISION WAS MADE OVER THE SUPRAUMBILICAL HERNIA. THE HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. THE SAC WAS OPENED AND CONTAINED FAT. THE HERNIA DEFECT WAS ENLARGED TO ALLOW REDUCTION OF THE FAT. EXCESS FAT WAS EXCISED AND THE PERITONEUM WAS CLOSED WITH SUTURE. ANOTHER PIECE OF BARD FLAT MESH (DEVICE 2) WAS PLACED IN THE PLANE BETWEEN THE PERITONEUM AND FASCIA AND SECURED IN PLACE WITH SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "OMENTAL ADHESIONS TO THE MIDLINE ABDOMINAL WALL SUPERIORLY WITH SMALL BOWEL ADHESIONS TO THE INFERIOR ASPECT OF THE INCISION INTO THE RIGHT ABDOMINAL WALL WAS NOTED AND ADHESIONS WERE LYSED. OMENTAL ADHESIONS TO THE UPPER ASPEC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25595852 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "DIRECT RIGHT INGUINAL HERNIA WAS NOTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE FLOOR OF CANAL OF INGUINAL CANAL SUPERIOR TO EPIGASTRIC VESSELS AND PUBIC TUBERCLE USING SUTURES." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "A LARGE DEFECT WAS NOTED JUST MEDIAL TO THE INTERNAL RING. A BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE FLOOR OF INGUINAL CANAL AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE BARD FLAT MESH (DEVICE 3). PER OP NOTES, "THE RIGHT-SIDED LAPAROSCOPIC INGUINAL HERNIA REPAIR WAS INTACT. ON LEFT, DIRECT INGUINAL HERNIA WAS IDENTIFIED. A BARD FLAT MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN WITHIN THE PREPERITONEAL SPACE. A SYNTHETIC MESH WAS SITUATED IN PLACE AND PERITONEUM AND CLOSED OVERUSING TACKS." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LE

  Patient problems: Hernia

  MAUDE report 25360132 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "DIRECT RIGHT INGUINAL HERNIA WAS NOTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE FLOOR OF CANAL OF INGUINAL CANAL SUPERIOR TO EPIGASTRIC VESSELS AND PUBIC TUBERCLE USING SUTURES." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "A LARGE DEFECT WAS NOTED JUST MEDIAL TO THE INTERNAL RING. A BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE FLOOR OF INGUINAL CANAL AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE BARD FLAT MESH (DEVICE 3). PER OP NOTES, "THE RIGHT-SIDED LAPAROSCOPIC INGUINAL HERNIA REPAIR WAS INTACT. ON LEFT, DIRECT INGUINAL HERNIA WAS IDENTIFIED. A BARD FLAT MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN WITHIN THE PREPERITONEAL SPACE. A SYNTHETIC MESH WAS SITUATED IN PLACE AND PERITONEUM AND CLOSED OVERUSING TACKS." ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT

  Patient problems: Hernia

  MAUDE report 25358701 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "DIRECT RIGHT INGUINAL HERNIA WAS NOTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE FLOOR OF CANAL OF INGUINAL CANAL SUPERIOR TO EPIGASTRIC VESSELS AND PUBIC TUBERCLE USING SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿A LARGE DEFECT WAS NOTED JUST MEDIAL TO THE INTERNAL RING. A BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE FLOOR OF INGUINAL CANAL AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE BARD FLAT MESH (DEVICE 3). PER OP NOTES, "THE RIGHT-SIDED LAPAROSCOPIC INGUINAL HERNIA REPAIR WAS INTACT. ON LEFT, DIRECT INGUINAL HERNIA WAS IDENTIFIED. A BARD FLAT MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN WITHIN THE PREPERITONEAL SPACE. A SYNTHETIC MESH WAS SITUATED IN PLACE AND PERITONEUM AND CLOSED OVERUSING TACKS." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL

  Patient problems: Hernia

  MAUDE report 25358699 ↗
• InjuryMay 19, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "AN INDIRECT HERNIA SAC WAS SEPARATED FROM THE CORD STRUCTURE. THE HERNIA SAC WAS PUSHED BACK THROUGH THE INTERNAL RING AND HELD IN PLACE WITH A PERFIX PLUG (DEVICE 1). AN ONLAY MESH WAS PLACED OVER THE FLOOR OF INGUINAL CANAL USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "THE MESH WAS FOUND ANTERIOR TO THE CORD. A DIRECT INGUINAL FLOOR HERNIA WAS NOTED. THE MESH (DEVICE 1) WAS ADHERENT TO THE POSTERIOR ASPECT OF THE EXTERNAL OBLIQUE WAS FREED UP AND REMOVED. THE BARD FLAT MESH (DEVICE 2) WAS PLACED INTO DEFECT AND SUTURED."

  Patient problems: Inflammation

  MAUDE report 25215611 ↗
• InjuryMay 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2003, PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MEHS (DEVICE 1). PER OPERATION NOTES, "THREE HERNIA SACS WERE IDENTIFIED AND DISSECTED FREE. THE HERNIA SACS WERE ENTERED AND EVACUATED THE OMENTUM. ADHESIONS BETWEEN HERNIA SAC AND OMENTUM WERE LYSED. THE HERNIA SACS WERE CONNECTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED." ON (B)(6) 2006, PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE 2) AND VENTRALEX MESH (DEVICE 3). PER OPERATION NOTES, "PREVIOUS INCISION WAS OPENED. THE HERNIA SAC CONTAINS OMENTUM WAS TAKEN DOWN. THE DEFECT WAS JUST TO THE RIGHT OF MIDLINE JUST ABOVE THE UMBILICUS. THERE WAS A SLIGHT EVENTRATION OF ABDOMINAL WALL WITH OVERLYING MESH (DEVICE 1) STILL PRESENT CREATING A HERNIA RECURRENCE. A COMPOSIX E/X (DEVICE 2) AND VENTRALEX MESH (DEVICE 3) WERE PLACED TO COVER THE DEFECT AND SUTURED." ON (B)(6) 2007, PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH INFECTED HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF BARD FLAT MESH (DEVICE 1), COMPOSIX E/X (DEVICE 2)

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 25171999 ↗
• InjuryMay 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED OUT. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA; SCAR TISSUE HEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2) AND EXPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH OLD INCISIONAL SITE. THE HERNIA SAC WAS DISSECTED OUT. THE PRIOR (DEVICE 1) WAS IDENTIFIED WHICH WAS REMOVED ENTIRELY. A BARD FLAT MESH (DEVICE 2) WAS PLACED INTO THE LEFT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESH (DEVICE 3 ¿ LEFT AND DEVICE 4 ¿ RIGHT). PER OPERATIVE NOTES, ¿AN INFRAUMBILICAL INCISION WAS MADE IN THE PRIOR UMBILICAL HERNIA SCAR. BOTH HERNIA SACS WERE DISSECTED OUT. TWO 3DMAX MESH (DEVICE 3 ¿ LEFT AND DEVICE 4 ¿ RIGHT) WAS

  Patient problems: Hernia

  MAUDE report 25163529 ↗
• InjuryMay 7, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH MIDLINE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN ELLIPTICAL INCISION WAS MADE AROUND THE PREVIOUS SKIN INCISION. THE HERNIA SAC WAS DISSECTED OUT. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE THROUGH PREVIOUS SKIN INCISION SITE. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED (DEVICE 1) THAT WAS PRESENT AND IT WAS IN GOOD CONDITION. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, AND RIGHT LOWER QUADRANT HERNIA, SCAR TISSUE, ADHESION, PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 3) AND BARD FLAT MESH (DEVICE 4). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE MIDLINE FROM THE XIPHOID. THE PREVIOUSLY PLACED MESHES (DEVICE 1 AND DEVICE 2) WERE PRE

  Patient problems: Abdominal Pain

  MAUDE report 25110834 ↗
• InjuryMay 7, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH MIDLINE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN ELLIPTICAL INCISION WAS MADE AROUND THE PREVIOUS SKIN INCISION. THE HERNIA SAC WAS DISSECTED OUT. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE THROUGH PREVIOUS SKIN INCISION SITE. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED (DEVICE 1) THAT WAS PRESENT AND IT WAS IN GOOD CONDITION. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, AND RIGHT LOWER QUADRANT HERNIA, SCAR TISSUE, ADHESION, PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 3) AND BARD FLAT MESH (DEVICE 4). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE MIDLINE FROM THE XIPHOID. THE PREVIOUSLY PLACED MESHES (DEVICE 1 AND DEVICE 2) WERE PRE

  Patient problems: Abdominal Pain; Adhesion(s); Hernia

  MAUDE report 25110828 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, "IN THE LOWER MIDLINE IN UPPER PORTION OF PRIOR C-SECTION WOUND, AN INCISIONAL HERNIA WITH SAC WAS DISSECTED OUT OF THE SUBCUTANEOUS TISSUE DOWN TO THE FASCIAL RING. A SMALL HERNIA IN THE PERITONEAL SPACE NEAR THE LEVEL OF UMBILICUS WAS NOTED. BOTH HERNIAS WERE COMMUNICATED AND MADE INTO A SINGLE HERNIA. THE PERITONEUM WAS CLOSED WITH SUTURES, AND A PIECE OF BARD FLAT MESH (DEVICE 1) WAS PLACED ABOVE THE LEVEL OF THE PERITONEUM AND SUTURED PERIPHERALLY. A SECOND PIECE OF BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE TOP OF THE FASCIA AND SECURED WITH SUTURES. THE WOUND WAS IRRIGATED AND REAPPROXIMATED WITH SUTURES." ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 3 AND 4). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC R

  Patient problems: Hernia

  MAUDE report 24938600 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, "IN THE LOWER MIDLINE IN UPPER PORTION OF PRIOR C-SECTION WOUND, AN INCISIONAL HERNIA WITH SAC WAS DISSECTED OUT OF THE SUBCUTANEOUS TISSUE DOWN TO THE FASCIAL RING. A SMALL HERNIA IN THE PERITONEAL SPACE NEAR THE LEVEL OF UMBILICUS WAS NOTED. BOTH HERNIAS WERE COMMUNICATED AND MADE INTO A SINGLE HERNIA. THE PERITONEUM WAS CLOSED WITH SUTURES, AND A PIECE OF BARD FLAT MESH (DEVICE 1) WAS PLACED ABOVE THE LEVEL OF THE PERITONEUM AND SUTURED PERIPHERALLY. A SECOND PIECE OF BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE TOP OF THE FASCIA AND SECURED WITH SUTURES. THE WOUND WAS IRRIGATED AND REAPPROXIMATED WITH SUTURES." ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 3 AND 4). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC RE

  Patient problems: Hernia

  MAUDE report 24938596 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, "IN THE LOWER MIDLINE IN UPPER PORTION OF PRIOR C-SECTION WOUND, AN INCISIONAL HERNIA WITH SAC WAS DISSECTED OUT OF THE SUBCUTANEOUS TISSUE DOWN TO THE FASCIAL RING. A SMALL HERNIA IN THE PERITONEAL SPACE NEAR THE LEVEL OF UMBILICUS WAS NOTED. BOTH HERNIAS WERE COMMUNICATED AND MADE INTO A SINGLE HERNIA. THE PERITONEUM WAS CLOSED WITH SUTURES, AND A PIECE OF BARD FLAT MESH (DEVICE 1) WAS PLACED ABOVE THE LEVEL OF THE PERITONEUM AND SUTURED PERIPHERALLY. A SECOND PIECE OF BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE TOP OF THE FASCIA AND SECURED WITH SUTURES. THE WOUND WAS IRRIGATED AND REAPPROXIMATED WITH SUTURES." ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 3 AND 4). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC R

  Patient problems: Hernia

  MAUDE report 24938593 ↗
• InjuryMar 25, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1 AND 2). PER OP NOTES, ¿THE HERNIA SACS WERE IDENTIFIED BILATERALLY AND MOBILIZED. THE SACS WERE TRANSECTED. A BARD FLAT MESH (DEVICE 1) ON RIGHT SIDE AND ANOTHER BARD FLAT MESH (DEVICE 2) ON LEFT SIDE WERE PLACED AND SECURED USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH POST OPERATIVE WOUND INFECTION AND BILATERAL INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF BARD FLAT MESH (DEVICE 1) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, DRAINING SITES WERE NOTED AND EXCISED. THE OLD MESH (DEVICE 1) WAS SLIGHTLY DISPLACED AROUND THE TESTICULAR CORD CREATING TIGHT ADHESIONS AROUND THE CORD AND IT WAS TEDIOUSLY MOBILIZED AND ADHESIONS WERE TAKEN DOWN. THE OLD MESH (DEVICE 1) WAS EXCISED ENTIRELY. THE ILIOINGUINAL AND GENITOFEMORAL NERVES WERE IDENTIFIED AND SOME SECTIONS WERE TRANSECTED. A BIOLOGICAL MESH WAS PLACED AND TACKED. ON THE LEFT INGUINAL REGION, THE MESH (DEVICE 2) WAS NOT VISIBLE. THE ILIOINGUINAL AND GENITOFEMORAL NERVES BETWEEN INTERNAL AND EXTERNAL OBLIQUE WE

  Patient problems: Nerve Damage; Pain

  MAUDE report 24690104 ↗
• MalfunctionMar 17, 2026Tear, Rip or Hole in Device Packaging

  AS REPORTED, THE OR NURSE OBSERVED SMALL HOLES IN THE PACKAGING OF A BARD FLAT MESH. TWO (2) ADDITIONAL PACKAGES FROM THE SAME BOX (PACKAGED THREE (3) PER CASE) WERE INSPECTED AND FOUND TO HAVE HOLES IN THE SAME LOCATION. ON THE OUTSIDE OF THE BOX THERE WERE FOUR (4) HOLES, SUGGESTING THAT SOMETHING HAD BEEN STAPLED TO THE BOX IN TWO (2) SEPARATE AREAS. IT APPEARS THE STAPLES PENETRATED THE OUTER BOX AND PUNCTURED ALL MESH PACKAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618188 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013: PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL SCROTAL HERNIA AND RIGHT SIDED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE LEFT SIDE, A LARGE INDIRECT SAC WITH OMENTAL INCARCERATION DOWN IN SCROTUM WAS NOTED. THE SAC WAS DISSECTED AND LIGATED, THE SAC WAS CLOSED PRIMARILY, AND BARD FLAT MESH (DEVICE 1) WAS PLACED TO THE INGUINAL LIGAMENT AND SECURED WITH SUTURES. IN THE RIGHT SIDE, A HERNIA IN THE DIRECT FLOOR ORIGINATING FROM PRIOR PROSTATECTOMY INCISION AND ANOTHER HERNIA PASSING DOWN INTO SCROTUM WITH LARGE SCROTAL SAC WAS NOTED. THE ENTIRE DIRECT FLOOR HAD TO BE PATCHED ALL THE WAY TO THE MIDLINE. THE DEFECT DENSELY ADHERENT IN SCROTUM AND SAC WAS AMPUTATED AND REDUCED. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES. ANOTHER BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE DIRECT HERNIA DEFECT AND SECURED THE MESH (DEVICE 2) WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE 3 AND 4). PER OPERATIVE NOTES, ¿A DIRECT FL

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24545350 ↗
• InjuryFeb 18, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2005- PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿OLD MIDLINE SCAR WAS EXCISED. THE HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL CAVITY AND WAS DISSECTED. A BARD FLAT MESH (DEVICE 1) WAS CUT AND SUTURED TO THE ANTERIOR FASCIA¿. (B)(6) 2005- PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF A BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿OLD SCAR WAS EXCISED. THE LATERAL PORTION OF THE CLOSURE WAS HERNIA WHICH WAS THEN EXCISED. A BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THIS REPAIR AND SUTURED.¿ (NOTE: BARD FLAT MESH (DEVICE 1) WAS NOT SEEN DURING THIS PROCEDURE) (B)(6) 2006- PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH. PER OP NOTES, ¿A HERNIA SAC WAS IDENTIFIED IN THE UMBILICAL REGION AND WAS DISSECTED. A 3 X 4 INCH PIECE OF MESH (KUGEL PATCH) WAS CUT AND SUTURED TO THE ANTERIOR FASCIA WITH SUTURES¿. (B)(6) 2007- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, CHRONIC ABDOMINAL PAIN, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (D

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 24376763 ↗
• InjuryFeb 5, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 1, 2). (NOTE: THERE WAS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 3, DEVICE 4). PER OP NOTES, ¿ATTENTION TO THE RIGHT GROIN, PATIENT WAS NOTED TO HAVE SMALL DIRECT INGUINAL HERNIA. THE MESH (DEVICE 1) FROM PREVIOUS REPAIR WAS IDENTIFIED. A LARGE RENT WAS FIXED TO PREVIOUS MESH. A PIECE OF BARD FLAT MESH (DEVICE 3) WAS INSERTED INTO PREPERITONEAL SPACE AND LAID FLAT IN SPACE TO REPAIR DIRECT HERNIA DEFECT USING TACKS. ATTENTION TO LEFT GROIN, THERE WAS A LEFT INGUINAL HERNIA. A PIECE OF BARD FLAT MESH (DEVICE 4) WAS PLACED INTO DEFECT AND SECURED USING TACKS.¿ (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN AND RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1, 3). PER OP NOTES, ¿ON RIGHT GROIN, A LARGE AMOUNT OF SCAR TISSUE WAS NOTED. THE PALPABLE PORTION OF MESH (DEVICE 1, 3) WAS EXCI

  Patient problems: Adhesion(s); Bacterial Infection; Fibrosis; Pain; Scar Tissue

  MAUDE report 24267133 ↗
• InjuryFeb 4, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 1, 2). (NOTE: THERE WAS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 3, DEVICE 4). PER OP NOTES, ¿ATTENTION TO THE RIGHT GROIN, PATIENT WAS NOTED TO HAVE SMALL DIRECT INGUINAL HERNIA. THE MESH (DEVICE 1) FROM PREVIOUS REPAIR WAS IDENTIFIED. A LARGE RENT WAS FIXED TO PREVIOUS MESH. A PIECE OF BARD FLAT MESH (DEVICE 3) WAS INSERTED INTO PREPERITONEAL SPACE AND LAID FLAT IN SPACE TO REPAIR DIRECT HERNIA DEFECT USING TACKS. ATTENTION TO LEFT GROIN, THERE WAS A LEFT INGUINAL HERNIA. A PIECE OF BARD FLAT MESH (DEVICE 4) WAS PLACED INTO DEFECT AND SECURED USING TACKS.¿ (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN AND RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1, 3). PER OP NOTES, ¿ON RIGHT GROIN, A LARGE AMOUNT OF SCAR TISSUE WAS NOTED. THE PALPABLE PORTION OF MESH (DEVICE 1, 3) WAS EXC

  Patient problems: Adhesion(s); Bacterial Infection; Hernia; Pain; Scar Tissue

  MAUDE report 24256320 ↗
• InjuryFeb 4, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 1, 2). (NOTE: THERE WAS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESHES (DEVICE 3, DEVICE 4). PER OP NOTES, ¿ATTENTION TO THE RIGHT GROIN, PATIENT WAS NOTED TO HAVE SMALL DIRECT INGUINAL HERNIA. THE MESH (DEVICE 1) FROM PREVIOUS REPAIR WAS IDENTIFIED. A LARGE RENT WAS FIXED TO PREVIOUS MESH. A PIECE OF BARD FLAT MESH (DEVICE 3) WAS INSERTED INTO PREPERITONEAL SPACE AND LAID FLAT IN SPACE TO REPAIR DIRECT HERNIA DEFECT USING TACKS. ATTENTION TO LEFT GROIN, THERE WAS A LEFT INGUINAL HERNIA. A PIECE OF BARD FLAT MESH (DEVICE 4) WAS PLACED INTO DEFECT AND SECURED USING TACKS.¿ (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN AND RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1, 3). PER OP NOTES, ¿ON RIGHT GROIN, A LARGE AMOUNT OF SCAR TISSUE WAS NOTED. THE PALPABLE PORTION OF MESH (DEVICE 1, 3) WAS EXC

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Bowel Perforation; Hernia; Pain

  MAUDE report 24256198 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED IN THE FLOOR OF THE RIGHT INGUINAL REGION. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE DEFECT AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2), BARD FLAT MESH (DEVICE 3) AND A SYNTHETIC MESH. PER OP NOTES, ¿HERNIA WAS NOTICED ON RIGHT AND LEFT SIDE OF THE INGUINAL REGION. ON THE RIGHT SIDE THERE WAS A LARGE DIRECT INGUINAL HERNIA. A LARGE 3DMAX MESH (DEVICE 2) WAS TRIMMED AND PLACED IN THE RIGHT INGUINAL REGION AND THE SYNTHETIC MESH WAS PLACED OVER THE 3DMAX MESH (DEVICE 2) AND TACKED. AGAIN A LARGE BARD FLAT MESH (DEVICE 3) WAS PLACED CUSTOMIZED, PLACED AND TACKED TO COOPER¿S LIGAMENT ACROSS THE TOP OF FASCIA.¿. ON (B)(6) 2019- PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT INGUINAL HERNIA WITH PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A RECURRENT DIRECT DEFECT ON THE RIGHT S

  Patient problems: Hernia; Pain

  MAUDE report 23897313 ↗