KUGELRecalls & reported problems across all models

We found 10 models of KUGEL by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 263 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2015 and Aug 26, 2026 — classified as 254 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (206 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported KUGEL problems

KUGEL models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Kugel 0010101

  Mesh, surgical, polymeric
  122 reports
• Kugel 0010105

  Mesh, surgical, polymeric
  42 reports
• Kugel 0010103

  Mesh, surgical, polymeric
  25 reports
• KUGEL 0115808

  Mesh, surgical, polymeric
  20 reports
• KUGEL 0115810

  Mesh, surgical, polymeric
  17 reports
• Kugel 0010102

  Mesh, surgical, polymeric
  16 reports
• KUGEL 0115814

  Mesh, surgical, polymeric
  9 reports
• Kugel 0010104

  Mesh, surgical, polymeric
  5 reports
• KUGEL 0115816

  Mesh, surgical, polymeric
  4 reports
• KUGEL 0115812

  Mesh, surgical, polymeric
  3 reports

Recent KUGEL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Patient problems: Fibrosis; Nerve Damage; Pain

  MAUDE report 50458137 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Per information provided: On (b)(6) 2016 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of Modified Kugel Patch (Device 1 - Right and Device 2 - Left). Per operative notes, "A right groin incision was made to the external oblique which was dissected to the inguinal ligament. The hernia sac was dissected out. A Modified Kugel Patch (Device 1) was placed onto the right inguinal floor and secured it with sutures. A left groin incision was made in a symmetric mirror fashion, and the exposure was identical as described on the right. The hernia sac was dissected out. A Modified Kugel Patch (Device 2) was placed into the left inguinal floor and secured it with sutures." On (b)(6) 2018 - Patient was diagnosed with bilateral recurrent inguinal hernias, groin pain, adhesion thereby underwent laparoscopic repair with implant of 3DMax Light Mesh (Device 3 - Right and Device 4 - Left) and explant of Modified Kugel Patch (Device 1 and Device 2). Per operative notes, "A right groin incision was made through old incision. The hernia sac was dissected out. There was visible mesh (Device 1) protruding. The peritoneum was inadvertently entered. Prev

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50433162 ↗
• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2004 - Patient was diagnosed with recurrent ventral incisional hernia (x2) thereby underwent open repair with the implant of two Kugel Patch (Device 1 and 2). Per op notes, "In the lower portion, hernia sac was encountered. The upper border of the fascial defect was noted to be the edge of the previous Gore-Tex patch repair. The patient had a history of a previous hernia repair with mesh. A medium Kugel Patch (Device 1) was placed over the defect using prolene sutures. The fascia at the midline was closed; the Gore-Tex patch to the edge of the fascia, where it had pulled away. The upper portion of the scar was incised; the hernia sac was encountered. A large Kugel Patch (Device 2) was placed beneath the previous Gore-Tex patch." (Note: The previously placed Gore-Tex patch was unknown during this procedure)(b)(6) 2015 - Patient was diagnosed with sepsis, small bowel obstruction and had abdominal pain thereby underwent lysis of adhesions. Per op notes, "Two layers of abdominal wall mesh (Device 1 and 2) were encountered into the abdomen. There were omental and small bowel adhesions to the abdominal wall mesh. Lysis of adhesions was performed."

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion; Sepsis

  MAUDE report 50078388 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1). PER OP NOTES, "THE OLD INCISION WAS OPENED. THE MESH WAS NOTED TO BE BULGED. IT WAS OPENED AND CUT AWAY. A MEDIUM KUGEL PATCH (DEVICE 1) WAS PLACED IN THE UNDERSIDE OF THE FASCIA AND SECURED WITH SUTURE. AND THE MESH WHICH LEFT WAS SECURED WITH SUTURE." (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN). (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "A TRANSVERSE INCISION WAS MADE ABOVE THE UMBILICUS. A FASCIAL DEFECT WAS IDENTIFIED ON THE LEFT OF THE MIDLINE AND NO SIGNIFICANT HERNIA SAC WAS PRESENT. THE SUTURES FROM THE PREVIOUS REPAIR IN THE MESH WERE PRESENT AND WERE REMOVED. THE OMENTUM WAS ADHERENT TO THE ANTERIOR ABDOMINAL WALL AROUND THE FASCIAL DEFECT AND WAS FREED UP. A LARGE VENTRALEX MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURED WITH SUTURES." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF KUGEL PATCH (DEVICE 1) AND VENTRALEX

  Patient problems: Fibrosis; Hernia; Inflammation

  MAUDE report 25215616 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INDIRECT TYPE INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1 AND 2). PER OP NOTES, ¿AN INCISION WAS MADE ABOVE THE MIDPOINT IN THE LEFT INGUINAL LIGAMENT. A SMALL INDIRECT INGUINAL HERNIA SAC WAS IDENTIFIED AND REDUCED. A SMALL KUGEL PATCH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES. AN INCISION WAS MADE IN THE RIGHT INGUINAL LIGAMENT. A SMALL INDIRECT HERNIA WAS NOTED ON THE RIGHT AND REDUCED INTO THE ABDOMINAL CAVITY. A SMALL KUGAL PATCH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3). PER OP NOTES, ¿A LEFT UPPER QUADRANT INCISION WAS MADE. BILATERAL PREPERITONEAL MESHES (DEVICE 1 AND 2) WERE IDENTIFIED. BILATERAL MEDIAL RECURRENCES WERE NOTED. ON THE LEFT SIDE, THE INFERIOR EPIGASTRIC WAS COMPLETELY FUSED WITH THE MESH (DEVICE 1) NEAR ITS INSERTION AT THE INGUINAL RING AND IT WAS DIVIDED. A 3DMAX MESH (DEVICE 3) WAS PLACED AND SECURED TOGETHER AT THE MIDLINE WITH SUTURE.¿

  Patient problems: Hernia

  MAUDE report 24940426 ↗
• InjuryApr 2, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2026 THE PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANTATION OF A MODIFIED KUGEL PATCH. POSTOPERATIVELY, THE PATIENT PRESENTED WITH "PAIN IN THE OPERATIVE AREA, PHYSICAL EXAMINATION REVEALED THAT THE UPPER PORTION OF THE INCISION WAS RED, SWOLLEN, HYPERTONIC, AND NON-FLUCTUATING, A LIGHT RED CLEAR FLUID WAS VISIBLE ON PROBING AND FLUID BUILDUP OCCURS IN THE PATIENT'S WOUND."

  Patient problems: Erythema; Implant Pain; Seroma; Swelling/ Edema

  MAUDE report 24766458 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2026 THE PATIENT UNDERWENT RIGHT-SIDED DIRECT INGUINAL HERNIA REPAIR WITH IMPLANTATION OF A MODIFIED KUGEL PATCH. POSTOPERATIVELY, THE PATIENT PRESENTED WITH "WITH SLIGHT PAIN IN THE OPERATIVE AREA, PHYSICAL EXAMINATION, REDNESS AND SWELLING IN THE UPPER PART OF THE INCISION, HIGH TENSION, NO FLUCTUATING SENSATION, AND OOZING OF LIGHT RED CLEAR FLUID ON PROBING, WITH ENHANCED ATTENTION."

  Patient problems: Erythema; Implant Pain; Seroma; Swelling/ Edema

  MAUDE report 24741642 ↗
• InjuryMar 31, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 1) AND KUGEL HERNIA PATCH (DEVICE 2). PER OP NOTES, "A VENTRIO ST MESH (DEVICE 1) AND A KUGEL HERNIA PATCH (DEVICE 2) WERE PLACED TO THE ABDOMINAL WALL USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "INCISION WAS MADE OVER THE HERNIA DEFECT, CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE. A SYNTHETIC MESH WAS PLACED TO THE DEFECT USING SUTURES." (B)(6) 2017 - PATIENT HAD ABDOMINAL WALL ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS WITH EXCISION OF CHRONIC CYST/ABSCESS CAVITY. PER OP NOTES, "THERE WAS PURULENT FLUID, WHICH WAS ASPIRATED OUT." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, INFECTED MESH AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2). PER OP NOTES, "THE ANTERIOR VENTRAL INCISIONAL HERNIA WHERE THE PRIOR MESH HAD BROKEN DOWN AND SEPARATED IN THE MIDLINE. PERFORMED LYSIS OF ADHESIONS, INFLAMMATORY MASS OF THE MESHOMA WERE TOOK DOWN. EXCISED THE CHRO

  Patient problems: Hernia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 24741223 ↗
• InjuryMar 2, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL HERNIA PATCHES (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, THE HERNIA DEFECTS WERE NOTED AND REDUCED. A KUGEL HERNIA PATCH (DEVICE 1 - RIGHT) WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, A LARGE HERNIA DEFECT WAS NOTED WITH PERITONEAL FAT WERE REDUCED. A KUGEL HERNIA PATCH (DEVICE 2 - LEFT) WAS PLACED AND SUTURED.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF KUGEL HERNIA PATCH (DEVICE 2), IMPLANT OF 3DMAX (DEVICE 3) AND BARD SOFT MESH (DEVICE 4). PER OP NOTES, ¿PREVIOUS LEFT GROIN INCISION WAS OPENED. THE SCAR TISSUE WAS EXCISED. THE PRIOR MESH (DEVICE 2) WAS NOTED ROLLED UP WAS EXCISED AND REMOVED. THE RECURRENT HERNIA IS ON THE LATERAL SIDE OF OLD MESH. THE HERNIA WAS REDUCED. ADHESIONS WERE LYSED. A 3DMAX (DEVICE 3) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED. A BARD SOFT MESH (DEVICE 4) WAS PLACED AS OVERLAP AND SUTURED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABSCESS AND INFECTED LEFT GROIN MESH THEREBY UNDERWENT OPE

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

  MAUDE report 24485955 ↗
• InjuryFeb 27, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF MODIFIED KUGEL HERNIA PATCH (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, A LARGE DIRECT HERNIA DEFECT WAS NOTED WITH BOWEL CONTENTS IN SCROTUM WERE REDUCED. A MODIFIED KUGEL HERNIA PATCH (DEVICE 1) WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, A DIRECT HERNIA DEFECT WAS NOTED AND REDUCED. A MODIFIED KUGEL HERNIA PATCH (DEVICE 2) WAS PLACED AND SUTURED¿. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF MODIFIED KUGEL HERNIA PATCH (DEVICE 2) AND IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, ¿THE PREVIOUS MESH (DEVICE 2) WAS STUCK IN INCISION SITE AND CURLED UP AND NOT COVERING THE DEFECT. A NEW DEFECT WAS IDENTIFIED OVER THIS. THE HERNIA SAC WAS REDUCED. THE PRIOR MESH (DEVICE 2) WAS EXCISED. A BARD FLAT MESH (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ADHESIONS AND MESH PROTRUSION ON RIGHT GROIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF MODIFIED KUGEL HERNIA PATCH (DEVICE 1). PER OP NO

  Patient problems: Hernia

  MAUDE report 24469926 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH MID EPIGASTRIC INCISIONAL HERNIA AND LEFT PERIUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND KUGEL PATCH (DEVICE 2). PER OP NOTES, ¿AN INCISION WAS MADE IN THE PREVIOUS GASTRIC UPPER MIDLINE INCISION OVER THE BULGING AREA OF MID EPIGASTRIC REGION. THE FASCIAL DEFECT WAS DELINEATED, AND A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED BELOW THE DEFECT IN THE PERITONEAL CAVITY AND SECURED WITH SUTURES. THE VENTRAL HERNIA WAS IDENTIFIED IN THE PERIUMBILICAL REGION TO THE LEFT, AND AN INCISION WAS MADE IN THE LEFT SIDE OF UMBILICUS REGION. A KUGEL PATCH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1) AND KUGEL PATCH (DEVICE 2). PER OP NOTES, ¿THE PRIOR MIDLINE INCISION WAS INCISED. THE DUAL MESH AND THE INFERIOR EDGE OF THE MESH WAS IDENTIFIED. THE UNDERSURFACE OF THE PATCH WAS FREED FROM ADHESIONS AND DIVIDED IN THE MIDLINE. OMENTUM WAS DENSELY ADHERENT TO THE PROXIMAL PORTION OF THE PATCH AND DISSECTED FREE. MULTIPLE ROUGH AND PO

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 24466399 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT INDIRECT WITH DIRECT ATTENUATION AND RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1 AND 2) IN THE LEFT AND (DEVICE 3 AND 4) IN THE RIGHT. PER OP NOTES, ¿A LEFT TRANSVERSE INGUINAL INCISION WAS MADE. AN INDIRECT HERNIA SAC WAS IDENTIFIED AND NOTED A LOOP OF SIGMOID COLON ADHERENT TO IT WAS TAKEN DOWN. AND THE HERNIA SAC WAS LIGATED. A KUGEL PATCH (DEVICE 1 AND 2) WERE PLACED IN THE PREPERITONEAL SPACE AND SECURED WITH SUTURE. A RIGHT INGUINAL INCISION WAS MADE AND A DIRECT RIGHT INGUINAL HERNIA WAS IDENTIFIED. A KUGEL PATCH (DEVICE 3 AND 4) WERE PLACED AND SECURED WITH SUTURE.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH X2. PER OP NOTES, ¿A TRANSVERSE INCISION WAS MADE. THE LEFT RECURRENT INGUINAL HERNIA MESH (DEVICE 1 AND 2) WAS DISSECTED FROM THE ANTERIOR ABDOMINAL WALL. A SIGNIFICANT ADHESION OF SMALL BOWEL TO THE MESH (DEVICE 1 AND 2) WAS NOTED AND THIS WAS LEFT INTACT. A SYNTHETIC MESH WAS PLACED AND SECURED TO COOPER¿S LIGAMENT. THE OLD MESH (DEVICE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24337140 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH LEFT INDIRECT WITH DIRECT ATTENUATION AND RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1 AND 2) IN THE LEFT AND (DEVICE 3 AND 4) IN THE RIGHT. PER OP NOTES, ¿A LEFT TRANSVERSE INGUINAL INCISION WAS MADE. AN INDIRECT HERNIA SAC WAS IDENTIFIED AND NOTED A LOOP OF SIGMOID COLON ADHERENT TO IT WAS TAKEN DOWN. AND THE HERNIA SAC WAS LIGATED. A KUGEL PATCH (DEVICE 1 AND 2) WERE PLACED IN THE PREPERITONEAL SPACE AND SECURED WITH SUTURE. A RIGHT INGUINAL INCISION WAS MADE AND A DIRECT RIGHT INGUINAL HERNIA WAS IDENTIFIED. A KUGEL PATCH (DEVICE 3 AND 4) WERE PLACED AND SECURED WITH SUTURE.¿ ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH X2. PER OP NOTES, ¿A TRANSVERSE INCISION WAS MADE. THE LEFT RECURRENT INGUINAL HERNIA MESH (DEVICE 1 AND 2) WAS DISSECTED FROM THE ANTERIOR ABDOMINAL WALL. A SIGNIFICANT ADHESION OF SMALL BOWEL TO THE MESH (DEVICE 1 AND 2) WAS NOTED AND THIS WAS LEFT INTACT. A SYNTHETIC MESH WAS PLACED AND SECURED TO COOPER¿S LIGAMENT. THE OLD MESH (DEVICE 1

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24331231 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT INDIRECT WITH DIRECT ATTENUATION AND RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1 AND 2) IN THE LEFT AND (DEVICE 3 AND 4) IN THE RIGHT. PER OP NOTES, ¿A LEFT TRANSVERSE INGUINAL INCISION WAS MADE. AN INDIRECT HERNIA SAC WAS IDENTIFIED AND NOTED A LOOP OF SIGMOID COLON ADHERENT TO IT WAS TAKEN DOWN. AND THE HERNIA SAC WAS LIGATED. A KUGEL PATCH (DEVICE 1 AND 2) WERE PLACED IN THE PREPERITONEAL SPACE AND SECURED WITH SUTURE. A RIGHT INGUINAL INCISION WAS MADE AND A DIRECT RIGHT INGUINAL HERNIA WAS IDENTIFIED. A KUGEL PATCH (DEVICE 3 AND 4) WERE PLACED AND SECURED WITH SUTURE.¿ ON (B)(6) 2011 PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH X2. PER OP NOTES, ¿A TRANSVERSE INCISION WAS MADE. THE LEFT RECURRENT INGUINAL HERNIA MESH (DEVICE 1 AND 2) WAS DISSECTED FROM THE ANTERIOR ABDOMINAL WALL. A SIGNIFICANT ADHESION OF SMALL BOWEL TO THE MESH (DEVICE 1 AND 2) WAS NOTED AND THIS WAS LEFT INTACT. A SYNTHETIC MESH WAS PLACED AND SECURED TO COOPER¿S LIGAMENT. THE OLD MESH (DEVICE 1

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24321879 ↗
• InjuryJan 9, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC REDUCIBLE BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO KUGEL HERNIA PATCH (DEVICE 1 AND 2). PER OP NOTES, "TWO KUGEL HERNIA PATCH (DEVICE 1 - RIGHT AND 2 - LEFT) WERE PLACED ON BOTH RIGHT AND LEFT SIDE OF THE PREPERITONEAL SPACE USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "COULD PALPATE THE PREVIOUSLY PLACED MESH (DEVICE 1) THAT IS PRESENT IN THE PREPERITONEAL SPACE, IT APPEARS THAT THE DIRECT HERNIA RECURRENCE ON THE RIGHT SIDE. A SYNTHETIC MESH WAS PLACED. PATIENT WAS AGAIN NOTED TO HAVE A RECURRENCE OF THE DIRECT INGUINAL HERNIA ON THE LEFT SIDE, IDENTIFIED THE PREVIOUSLY PLACED MESH (DEVICE 2) AND A SYNTHETIC MESH WAS PLACED."

  Patient problems: Hernia

  MAUDE report 24020075 ↗

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