BARD 0117011Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741030888), received between Apr 20, 2017 and Jun 23, 2026 — classified as 38 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (24 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "AN INFRAUMBILICAL INCISION WAS MADE. THE HERNIA SAC WAS IDENTIFIED AND MOBILIZED. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURE." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, "A PERIUMBILICAL MIDLINE INCISION WAS MADE. THE HERNIA SAC WAS IDENTIFIED, REDUCED AND EXCISED. A VENTRALEX ST MESH (DEVICE 1) WAS NOTED TO BE CURLED UP AND EXCISED. A BARD SOFT MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES." (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 3). PER OP NOTES, "THE OLD SCAR WAS REOPENED. A LARGE HERNIA SAC WAS IDENTIFIED AND DISSECTED TO THE FASCIA. THE SAC WAS OPENED AND AMPUTATED. IT HAD INCARCERATED OMENTUM WITHIN IT. ANOTHER LARGE FASCIAL DEFECT WAS NOTED INFERIORLY. THE SKIN BRIDGE BETWEEN THE TWO WAS OPEN

  Patient problems: Hernia; Seroma

  MAUDE report 25591403 ↗
• InjuryMar 24, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THERE WAS A MIDLINE HERNIA AND WAS REPAIRED BY PLACING A SEPRAMESH IP (DEVICE 1) AND TACKED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA WITH SEROMA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1), IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE SEPRAMESH IP (DEVICE 1) WAS EXCISED. A BARD FLAT MESH (DEVICE 2) WAS PLACED UNDERSURFACE OF THE FASCIA AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH ADHESIONS TO ABDOMINAL WALL, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿SOME PORTIONS OF BARD SOFT MESH (DEVICE 2) WITH INFLAMMATORY REACTION WAS EXPLANTED AND SUTURED¿.

  Patient problems: Adhesion(s); Inflammation

  MAUDE report 24673243 ↗
• InjuryJan 2, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 1). PER OP NOTES, ¿A LARGE INDIRECT HERNIA WITH CORD LIPOMA WAS IDENTIFIED AND REDUCED. THE HERNIA SAC WAS DISSECTED OFF. A BARD SOFT MESH (DEVICE 1) WAS PLACED AND TACKED TO COOPERS LIGAMENT.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿A LARGE INDIRECT HERNIA SAC WAS IDENTIFIED AND OPENED. SOME OMENTUM AND SMALL BOWEL WERE REDUCED AND TRANSECTED. A LARGE PERFIX PLUG (DEVICE 2) WAS PLACED AND SUTURED TO PUBIC TUBERCLE.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF BARD SOFT MESH (DEVICE 1), PERFIX PLUG (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿EXTENSIVE SCARRING WAS NOTED IN EXTERNAL OBLIQUE. ADHESIONS WERE LYSED. THE CORD WAS DISSECTED FROM THE OLD MESHES (DEVICE 1 AND 2). VAS DEFERENCE WAS ADHERENT TO OLD MESH TAKEN DOWN. THE LAPAROSCOPICALLY PLACED OLD MESH (DEVICE 1) WAS BULGING AND PROTRUDING THROUGH THE F

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 23942384 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL/EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE JUST TO THE RIGHT OF THE UMBILICUS. THE HERNIA SAC WAS JUST ABOVE THE UMBILICUS WHICH WAS DISSECTED OUT. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE 1) AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE. THE HERNIA SAC WAS DISSECTED OUT. LYSIS OF ADHESION WAS PERFORMED. PREVIOUSLY PLACED BARD FLAT MESH (DEVICE 1) WAS REMOVED PARTIALLY. A BARD SOFT MESH (DEVICE 2) WAS PLACED AND SECURE IT WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, SCAR TISSUE, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A VERTICAL MIDLINE INCISION WAS MADE TO THE OLD SCAR. HERNIA SAC WAS DISSECTED OUT. OLD SCAR TISSUES AND ADHESIONS WERE TAKEN DOWN. PREVIOUSLY PLACED MESHES WERE W

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

  MAUDE report 23786675 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿TO THE RIGHT OF MIDLINE, A DIRECT HERNIA AND INDIRECT HERNIA IN THE LEFT SIDE WAS NOTED. BOTH HERNIAS WERE REDUCED AND TWO LARGE 3DMAX MESHES (DEVICE 1 AND 2) WERE PLACED OVER THE DEFECT IN THE RIGHT AND LEFT SIDE AND FASCIA WAS CLOSED SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH PRE-SHAPED (DEVICE 3). PER OPERATIVE NOTES, ¿A HERNIA DEFECT IN THE RIGHT UPPER ABDOMINAL WALL WAS NOTED AND REDUCED. THE DENSE SCAR TISSUE WAS REDUCED AND TO THE VENTRAL DEFECT, A PIECE OF BARD SOFT MESH PRE-SHAPED (DEVICE 3) WAS PLACED OVER THE FASCIA AND SUTURED IN PLACE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MIDLINE MESHES (DEVICE 1 AND 3) AND IMPLANT OF BARD SOFT MESH (DEVICE 4). PER OPERATIVE NOTES, ¿MULTIPLE HERNIA DEFECTS IN AND AROUND THE MIDLINE AND DENSE ADHESIONS TO ABDOMINAL WALL WAS REDUCED. THE MESH IN THE RIGHT OF MIDLINE (DEVICE 1) AND MESH

  Patient problems: Adhesion(s); Inflammation; Obstruction/Occlusion

  MAUDE report 23617232 ↗
• InjuryOct 30, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿THE VENTRAL HERNIA SAC WAS NOTED AND RESECTED. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SUTURED. A SMALL HIATAL HERNIA NOTED AND REPAIRED WITH SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿A LARGE HERNIA SAC WAS NOTED AND DISSECTED FREE. THE INCARCERATED OMENTUM WAS REDUCED. THE PRIOR MESH (DEVICE 1) WAS NOTED IN GOOD POSITION. A BARD SOFT MESH (DEVICE 2) WAS PLACED AND SUTURED WITH OLD MESH (DEVICE 1).¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INTRAMUSCULAR FOREIGN BODY WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF VENTRALEX (DEVICE 1) AND BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE PRIOR MESHES (DEVICE 1 AND 2) WERE NOTED. THE CORNER OF THE MESHES WERE FOLDED ON ITSELF AGAINST ABDOMINAL MUSCULATURE. THE CORNERS OF MESHES (DEVICE 1 AND 2) WERE EXCISED AND SUTURED.¿

  Patient problems: Pain

  MAUDE report 23424240 ↗
• InjurySep 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT PARAESOPHAGEAL HERNIA AND RECURRENT SUPRAPUBIC VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 1) AND SYNTHETIC MESH. PER OP NOTES, ¿ADHESIONS OF STOMACH WERE TAKEN DOWN. THE PARAESOPHAGEAL HERNIA SAC WAS NOTED AND REPAIRED USING SYNTHETIC MESH. THE SUPRAPUBIC VENTRAL HERNIA SAC WITH INCARCERATED PERITONEAL FAT WAS REDUCED. A BARD SOFT MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH LOWER ABDOMEN PAIN, BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL EXCISION OF BARD SOFT MESH (DEVICE 1) AND IMPLANT OF 3DMAX (DEVICE 2 AND 3). PER OP NOTES, ¿ADHESIONS WERE LYSED. THE PRIOR MESH (DEVICE 1) WAS NOTED AND DISSECTED FREE IN 3 TO 4 PIECES AND REMOVED. THE BILATERAL INGUINAL HERNIA SACS WERE NOTED AND TRANSECTED. TWO 3DMAX MESHES (DEVICE 2 - LEFT AND 3 ¿ RIGHT) WERE PLACED AND SUTURED. THE UMBILICAL HERNIA DEFECT WAS NOTED AND REPAIRED WITH SUTURES.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. (NOTE: THE PR

  Patient problems: Adhesion(s); Pain

  MAUDE report 23083328 ↗
• InjuryAug 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT RIGHT HERNIA REPAIR SURGERY WITH THE IMPLANT OF BARD FLAT MESH ON (B)(6) 2010. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE AND FURTHER REPARATIVE SURGERIES. AND POLYPROPYLENE SUTURE WAS USED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH BARD SOFT MESH AND SUBSEQUENT TO THE LATTER SURGERY, THE PLAINTIFF HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE WHICH RESULTED IN THE PATIENT REQUIRING VARIOUS ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Inflammation; Obstruction/Occlusion

  MAUDE report 22858260 ↗
• MalfunctionAug 13, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, AN OPEN INCARCERATED VENTRAL HERNIA REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE A SOFT MESH WAS PLACED IN A CONTRAINDICATED TISSUE PLANE (BOWEL). THE MESH REMAINS IMPLANTED AND AT THIS TIME THERE HAVE BEEN NO ISSUES DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792103 ↗
• MalfunctionAug 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, AN OPEN INCARCERATED VENTRAL HERNIA REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE A SOFT MESH WAS PLACED IN CONTACT WITH THE BOWEL, CONTRARY TO THE INSTRUCTIONS-FOR-USE. A SECOND FLAT MESH WAS ALSO IMPLANTED DURING THE SAME PROCEDURE, BUT AS REPORTED THIS MESH WAS NOT PLACED AGAINST THE BOWEL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784367 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010: PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A PERFIX PLUG MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, RIGHT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT A LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (LEFT SIDE ¿ DEVICE #2) AND RIGHT-SIDE BARD SOFT MESH (DEVICE #3, DEVICE #4). PER OPERATIVE NOTES, ¿ON LEFT SIDE ONE BARD SOFT MESH (DEVICE #2) WAS PLACED AND SUTURED. ON RIGHT SIDE HERNIA SAC WAS DISSECTED. TWO BARD SOFT MESH (DEVICE #3, DEVICE #4) WAS PLACED AND SUTURED.¿ ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH LEFT POST HERNIA INGUINODYNIA, PAIN, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG MESH (DEVICE #1) AND BARD SOFT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿SCAR TISSUES WERE DIVIDED. PERFIX PLUG MESH (DEVICE #1) AND BARD SOFT MESH (DEVICE #2) WAS EXCISED COMPLETELY.¿ ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH DEEP GROIN PAIN THEREBY UNDERWENT REPAIR WITH NERVE BLOCK, PLACED FENTANYL, GABAPENTIN, AND HYDROCODO

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 22531898 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿OLD BARD FLAT MESH (DEVICE #1) WAS EXCISED. ONE VENTRALIGHT ST MESH (DEVICE #2) AND ONE BARD SOFT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION, ADHESION, ABSCESS, MESH INFECTION, INFLAMMATION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3), LYSIS OF ADHESION, ABSCESS, AND IMPLANT ONE SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ABSCESS WERE DRAINED FROM INTRA-ABDOMINAL AREA. INFECTED VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3) WAS EXCISED COMPLETELY.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OLD BIOLOGICAL MESH

  Patient problems: Abscess; Bowel Perforation; Unspecified Infection

  MAUDE report 22492563 ↗
• InjuryJun 24, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD PRESHAPED MESH (DEVICE #1). PER OP NOTES, ¿A LARGE INDIRECT HERNIA ALONG THE SPERMATIC CORD WAS NOTED. A ONLAY BARD PRESHAPED MESH (DEVICE #1) WAS PLACED INTO DEFECT AND SUTURED WITH A PUBIC TUBERCLE.¿ (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT SYMPTOMATIC RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE #2). PER OP NOTES, ¿SMALL INDIRECT SAC WAS ADHERENT TO THE SPERMATIC CORD. A SHEET OF BARD SOFT MESH (DEVICE #2) WAS PLACED TO COVER THE DEFECT IN INGUINAL FLOOR AND SECURED TO THE PERIOSTEUM ADJACENT TO THE PUBIS AND RIGHT COOPER LIGAMENT USING TACKS.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE REMOVAL OF MESH (DEVICE #1, #2). PER OP NOTES, ¿THERE WERE SOME ADHESIONS IN THE RIGHT LOWER QUADRANT. IN THE MIDDLE PORTION, THERE WAS AN INTENSE INFLAMMATORY REACTION. THE PREVIOUSLY PLACED MESH (DEVICE #1, #2) HAD CONTRACTED AND FORMED A BALL WAS FREED OFF THE SPERMATIC CORD AND EXCISED. A SYNTHETIC MESH

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22313255 ↗
• InjuryJun 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE #1). PER OP NOTES, "A 3DMAX MESH (DEVICE #1) WAS PLACED AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE #2). PER OP NOTES, "A BARD SOFT MESH (DEVICE #2) WAS PLACED AND SUTURED." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF 3DMAX MESH (DEVICE #1) & BARD SOFT MESH (DEVICE #2) AND IMPLANT OF BARD SOFT MESH (DEVICE #3). PER OP NOTES, "ADHESIONS WERE LYSED. THE MESH (DEVICE #1 & #2) WAS REMOVED AND DISCARDED. A BARD SOFT MESH WAS PLACED AND SUTURED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22291215 ↗
• MalfunctionMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE, THE SOFT MESH TORE WHEN PULLED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099728 ↗
• InjuryMar 13, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF BARD SOFT MESHES (DEVICE #1 & #2) AND WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #3). PER OPERATIVE NOTES, "THE HERNIA WAS IDENTIFIED AND THE PERITONEUM WAS TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL. A RIGHT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED AND A BARD SOFT MESH (DEVICE #1) WAS ANCHORED TO COOPER'S LIGAMENT. A LEFT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED INTO ABDOMEN. ANOTHER BARD SOFT MESH (DEVICE #2) ANCHORED MEDIALLY TO COOPER'S LIGAMENT. THE INCISIONAL HERNIA WAS SEEN AND THE DEFECT WAS COVERED WITH A VENTRALEX ST (DEVICE #3) WAS PLACED AND SUTURED." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST (DEVICE #3) AND IMPLANT OF VENTRIO ST MESH (DEVICE #4). PER OPERATIVE NOTES, "THE PREVIOUS MESH (DEVICE #3) NOTED WITH A RECURRENCE INFERIORLY WITH PREPERITONEAL FAT. THE MESH (DEVICE #3) WAS DISSECTED OFF THE FASCIA. THE DEFECT WAS SEEN AND A

  Patient problems: Hernia

  MAUDE report 21593333 ↗
• InjuryMar 13, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2017 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF BARD SOFT MESHES (DEVICE #1 & #2) AND WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #3). PER OPERATIVE NOTES, "THE HERNIA WAS IDENTIFIED AND THE PERITONEUM WAS TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL. A RIGHT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED AND A BARD SOFT MESH (DEVICE #1) WAS ANCHORED TO COOPER'S LIGAMENT. A LEFT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED INTO ABDOMEN. ANOTHER BARD SOFT MESH (DEVICE #2) ANCHORED MEDIALLY TO COOPER'S LIGAMENT. THE INCISIONAL HERNIA WAS SEEN AND THE DEFECT WAS COVERED WITH A VENTRALEX ST (DEVICE #3) WAS PLACED AND SUTURED." (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST (DEVICE #3) AND IMPLANT OF VENTRIO ST MESH (DEVICE #4). PER OPERATIVE NOTES, "THE PREVIOUS MESH (DEVICE #3) NOTED WITH A RECURRENCE INFERIORLY WITH PREPERITONEAL FAT. THE MESH (DEVICE #3) WAS DISSECTED OFF THE FASCIA. THE DEFECT WAS SEEN AND A VE

  Patient problems: Hernia

  MAUDE report 21593116 ↗
• InjuryFeb 19, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2010 PATIENT WAS DIAGNOSED WITH RIGHT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OFF. THEN A COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED OVER THE DEFECT USING SUTURES.¿ ON (B)(6) 2015 PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INCISIONAL VENTRAL HERNIA, ADHESION AND MESH DEFORMATION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX KUGEL MESH (DEVICE #1) AND IMPLANT OF BARD SOFT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS THEN DIRECTLY APPROACHED, AND EASILY IDENTIFIED A HARD ATTENUATED MASS OF THE SHRUNKEN MESH (DEVICE #1). THIS ENTIRE MESH WAS FIRM, AND TIGHTLY ADHERENT TO THE SURROUNDING TISSUE, AND THE PERITONEUM, WHICH WAS DISSECTED AWAY. ENTIRE OLD MESH (DEVICE #1) WAS REMOVED OUT. AFTER COMPLETE DISSECTION OF THE HERNIA SAC, THE BARD SOFT MESH (DEVICE #2) WAS DESIGNED, AND REINFORCED THE ENTIRE LENGTH OF THE FASCIAL CLOSURE USING SUTURES.¿ ON (B)(6) 2017 PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A SYNTHETIC ME

  Patient problems: Hernia

  MAUDE report 21409480 ↗
• InjuryDec 19, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE #1) ON (B)(6) 2015. PER OPERATIVE NOTES, ¿THE PERITONEAL CONTENTS OFF THE CORD STRUCTURES AT THE LEVEL OF THE UMBILICUS WERE DISSECTED. A PIECE OF BARD SOFT MESH (DEVICE #1) WAS PLACED CENTERED ON THE INTERNAL RING, TUCKED DOWN UNDER THE PERITONEUM INFERIORLY.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD MESH PRE-SHAPED W/ KEYHOLE (DEVICE #2) AND PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿AN INDIRECT HERNIA SAC WAS IDENTIFIED. A EXTRA-LARGE PERFIX PLUG (DEVICE #3) WAS FIXED TO THE UNDERSURFACE OF THE DEFORMED ABDOMINAL WALL AND THE "SHUTTER" OF THE INTERNAL OBLIQUE. A BARD PRESHAPED W/ KEYHOLE PATCH (DEVICE #2) WAS PLACED AND THEN FIXED TO THE FASCIA OF THE INGUINAL FLOOR, AT THE PUBIS, ALONG THE SHELVING EDGE.¿ (NOTE, THERE WAS NO MENTION/VISUALIZATION OF DEVICE #1 DURING THE REPAIR) ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

  Patient problems: Hernia

  MAUDE report 18354281 ↗
• InjuryAug 11, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD SOFT MESH ON (B)(6) 2020. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 17507790 ↗
• InjuryJul 31, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD SOFT MESH ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD SOFT MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Insufficient Information

  MAUDE report 17422584 ↗
• InjuryJan 31, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH AND BARD SOFT MESH ON (B)(6) 2014 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16271069 ↗
• InjuryDec 12, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD SOFT MESH ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD SOFT MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12981903 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2004, THE PATIENT UNDERWENT SURGERY FOR AN INCISIONAL HERNIA REPAIR AND A BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH WAS IMPLANTED. IT IS ALLEGED THAT ON (B)(6) 2006 AND ON (B)(6) 2007, THE PATIENT UNDERWENT REVISION SURGERIES. IT IS ALSO ALLEGED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A REVISION SURGERY WITH IMPLANT OF A BARD/DAVOL SOFT MESH AND IN (B)(6) 2019 THE PATIENT UNDERWENT ANOTHER REVISION SURGERY. ATTORNEY ALLEGES THAT FURTHER TO IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF BOWEL COMPLICATIONS, MESH ADHESIONS, ABDOMINAL COMPLICATIONS AND CHRONIC PAIN. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. ATTORNEY ALLEGES THE PATIENT SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, SUFFERING AND PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Pain

  MAUDE report 12457956 ↗
• InjuryAug 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH A BARD/DAVOL SOFT MESH ON (B)(6) 2016. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF RECURRENT INGUINAL HERNIAS, INGUINODYNIA INCLUDING PERSISTENT RIGHT GROIN PAIN AND SEVERE LOWER ABDOMINAL PAIN, AND ADHESION INJURIES FROM THE ATTACHMENT OF THE SUPEROMEDIAL EDGE OF THE MESH TO THE TRANSVERSALIS FASCIA. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALSO ALLEGED THE PATIENT WAS TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS AND REST. ATTORNEY ALLEGES THAT THE PATIENT WILL REQUIRE FURTHER INVASIVE REPAIR SURGERY, PHYSIOTHERAPY, REHABILITATION AND WILL CONTINUE TO REQUIRE OTHER FORMS OF MEDICAL CARE. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12322174 ↗