Kugel 0010101Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741016332), received between Mar 23, 2015 and Apr 21, 2026 — classified as 117 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (95 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 122 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO KUGEL HERNIA PATCH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿AN INCISIONAL HERNIA FROM THE APPENDECTOMY SITE WAS REDUCED AND CLOSED PRIMARILY WITH SUTURES. IN THE LEFT GROIN, THE LARGE DIRECT DEFECT WAS NOTED AT INTERNAL RING AND DISSECTED. A KUGEL HERNIA PATCH (DEVICE 1) WAS PLACED AND SECURED IT WITH SUTURES. IN THE RIGHT GROIN, SIMILARLY A LARGE DEFECT WAS REDUCED AND ANOTHER KUGEL HERNIA PATCH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES. ¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE LEFT GROIN, THE TISSUES WERE DENSELY ADHERENT TO SURROUNDING TISSUES. THE MESH (DEVICE 1) WAS SEEN FREE ENTIRELY FROM INGUINAL LIGAMENT WHERE THE DIRECT DEFECT RECURRED. THE HERNIA WAS DISSECTED FREE AND ADHESIONS WERE LYSED. THE MEDIUM PERFIX PLUG (DEVICE 3) WAS PLACED OVER THE HERNIA AND PREVIOUSLY PLACED MESH (DEVICE 1) WAS SUTURED TO INGUINAL LIGAMENT AND IRRIGATED WITH SUTURES.¿ ON (B)(6) 2016 - PATI

  Patient problems: Hernia

  MAUDE report 23897315 ↗
• MalfunctionDec 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE KUGEL PATCH RUPTURED (TORE) WHILE BEING INSERTED WITH A RETRACTOR. PER INFORMATION REPORTED, KUGEL TECHNIQUE WAS PERFORMED WITHOUT A TROCAR. A NEW MESH WAS THEN INSERTED USING THE SAME METHOD AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. IT WAS REPORTED THAT THE INNER PACKAGING AND THE MESH WAS INTACT PRIOR TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881250 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH COMPLEX VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF KUGEL PATCHES (DEVICE 1, 2). PER OP NOTES, ¿LARGE AMOUNT OF ANTERIOR ABDOMINAL WALL ADHESIONS INCLUDING THE TRANSVERSE COLON WERE STUCK INSIDE THE VENTRAL HERNIA. A LARGE PIECE OF KUGEL PATCH (DEVICE 1) WAS PLACED IN ABDOMINAL CAVITY AND LAID AGAINST ANTERIOR ABDOMINAL WALL AND COVER THE LARGER DEFECT USING STAPLED. SUPERIORLY, PATIENT TWO SMALLER HERNIAS JUST ABOVE LARGER HERNIA. A KUGEL PATCH (DEVICE 2) WAS PLACED IN ANTERIOR ABDOMINAL WALL AND STAPLED CIRCUMFERENTIALLY.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿ADHESIONS WERE LYSED. THE HERNIA SAC AND MULTIPLE LOOPS OF SMALL BOWEL ADHERED TO SAC WERE EXCISED. THE MIDLINE ASPECT OF KUGEL PATCH (DEVICE 1, 2) AND RIND OF PLASTIC RING WAS REMOVED. THE WELL ADHESED MESH WAS LEFT IN PLACE. ALL METALLIC STAPLES WERE REMOVED. A BIOLOGICAL MESH WAS PLACED AND SECURED CIRCUMFERENTIALLY USING SUTURES.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23788644 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL, VENTRAL HERNIA, LARGE RIGHT INGUINAL HERNIA AND SMALL LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (RIGHT - DEVICE 1), KUGEL PATCH (LEFT ¿ DEVICE 2) AND VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿ON THE RIGHT SIDE, POSTERIOR FASCIA WAS OPENED, AND A MODERATE-SIZED DIRECT HERNIA MASS WAS REDUCED. A SMALL OVAL KUGEL PATCH (RIGHT ¿ DEVICE 1) WAS CONTOURED TO THE ABDOMINAL CONTENT. ON THE LEFT SIDE, A DIRECT HERNIA WAS IDENTIFIED. A SMALL OVAL KUGEL PATCH (LEFT - DEVICE 2) WAS CONTOURED TO THE ABDOMINAL CONTENT. THE WOUND WAS CLOSED. ON THE VENTRAL UMBILICAL HERNIA, A VENTRALEX ST MESH (DEVICE 3) WAS PLACED POSTERIORLY, AND THE FASCIA WAS CLOSED USING SUTURES". ON (B)(6) 2018 PATIENT WAS DIAGNOSED WITH PERFORATED DIVERTICULITIS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THERE WAS AN EXTREMELY LARGE MESENTERIC ABSCESS NOTED. IN THE MIDLINE, WHERE THE ANTERIOR ABDOMINAL WALL MESH WAS SEEN. THE VENTRALEX ST MESH (DEVICE 3) WAS IDENTIFIED AND REMOVED¿. ON (B)(6) 2018 PATIENT WAS DIAGNOSED WITH BILA

  Patient problems: Pain; Scar Tissue

  MAUDE report 23788637 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL HERNIA PATCH (DEVICE #1 & #2). PER OP NOTES, ¿THE HERNIA SAC ON THE LEFT SIDE WAS IDENTIFIED, DISSECTED AND REDUCED. A KUGEL HERNIA PATCH (DEVICE #1) WAS PLACED AND SUTURED. THE HERNIA SAC ON THE RIGHT SIDE WAS IDENTIFIED AND REDUCED. A KUGEL HERNIA PATCH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE #3 & #4). PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1) IN THE LEFT INGUINAL REGION APPEARED TO BE FOLDED SUPERIORLY LED TO RECURRENCE. THE HERNIA SAC WAS IDENTIFIED AND REPAIRED WITH 3DMAX LIGHT (DEVICE #3) AND SUTURED. THE HERNIA SAC IN RIGHT SIDE WAS IDENTIFIED AND REPAIRED USING 3DMAX LIGHT (DEVICE #4) AND SUTURED.

  Patient problems: Hernia; Pain

  MAUDE report 22724755 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH SMALL RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SMALL BARD KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿A SMALL BARD COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT SMALL BARD KUGEL PATCH (DEVICE #2). PER OPERATIVE NOTES, ¿A SMALL BARD KUGEL PATCH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THE PERFIX PLUG MESH (DEVICE #3). PER OPERATIVE NOTES, ¿A PERFIX PLUG MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MEDIUM PERFIX PLUG MESH (DEVICE #4). PER OPERATIVE NOTES, ¿A MEDIUM PERFIX PLUG MESH (DEVICE #4) WAS PLACED AND SUTURED.¿ THIS FILE REPRESENTS KUGEL PATCH (DEVICE #2).

  Patient problems: Hernia

  MAUDE report 22380497 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015: PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA & REDUCIBLE LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1) FOR EPIGASTRIC HERNIA & IMPLANT OF KUGEL HERNIA PATCH (DEVICE #2) FOR LEFT INGUINAL HERNIA. PER OP NOTES, ¿AN INCISION WAS MADE IN THE EPIGASTRIC HERNIA, VENTRALEX MESH (DEVICE #1) WAS PLACED IN THE PERIFASCIAL SPACE USING PROLENE SUTURES. AN INCISION WAS MADE IN THE LEFT LOWER INGUINAL AREA, A KUGEL HERNIA PATCH (DEVICE #2) WAS PLACED INTO THE PREPERITONEAL SPACE USING SUTURES.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RIGHT REDUCIBLE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL HERNIA PATCH (DEVICE #3). PER OP NOTES, ¿ON RIGHT SIDE, A KUGEL HERNIA PATCH (DEVICE #3) WAS PLACED INTO THE PREPERITONEAL SPACE AND WAS SUTURED TO COOPER¿S LIGAMENT. AN INCISION WAS MADE PARALLEL TO THE INGUINAL CANAL ON THE LEFT SIDE. THE PREVIOUS SCAR WAS ENTERED. THERE IS NO INDIRECT INGUINAL HERNIA. THERE IS A FATTY TYPE OF BULGE IN THE DIRECT INGUINAL SPACE, AND IT WAS REDUCED. THE MESH (DEVICE #2) IS NOTED TO BE RIGHT UNDER THIS. THE DISTAL LATERAL PORTION OF THE MESH IS FIRMLY

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22370504 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6)2004 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIAS AND CORD LIPOMAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #1 & LEFT - DEVICE #2). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL REGION, A SMALL RIGHT CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (RIGHT - DEVICE #1) WAS PLACED AND SUTURED. IN LEFT INGUINAL REGION, LARGE LEFT DIRECT HERNIA INCLUDING A SMALL CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (LEFT - DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6)2006 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL DIRECT INGUINAL HERNIAS THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #3 & LEFT - DEVICE #4). (NOTE, THERE WAS NO IMPLANT OP NOTES PROVIDED). (B)(6)2011 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #5) AND EXPLANT OF KUGEL PATCH (LEFT - DEVICE #2 & #4). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED KUGEL PATCH (LEFT - DEVICE #2 & #4) HAD MIGRATED INFERIORLY AT FEMORAL REGION WHICH WAS DISSECTED AWAY AND REMOVED. THE HERNIA SAC WAS DISSECTED AND A PERFIX PLUG (DEVICE #5) WAS PLACED INTO THE FEMORAL R

  Patient problems: Hernia

  MAUDE report 20876504 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #6. THE ARTICLE DESCRIBES A 74-YEAR-OLD MALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A KUGEL PATCH. THE ARTICLE STATES THERE WAS AN INTRAOPERATIVE COMPLICATION OF AN ¿INCIDENTAL ENTEROTOMY OF THE SMALL BOWEL SEVERELY ADHERED TO THE HERNIA SAC¿ ¿ THE INJURED PART OF THE BOWEL WAS CLOSED UNDER DIRECT VISION. SPILLAGE OF THE CONTENT TO THE SURGICAL FIELD WAS N

  Patient problems: Discomfort; Post Operative Wound Infection

  MAUDE report 18185258 ↗
• MalfunctionNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #7. THE ARTICLE DESCRIBES A 72-YEAR-OLD FEMALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A MEDIUM KUGEL PATCH. THE ARTICLE NOTES THE PATIENT EXPERIENCED POST OPERATIVE PAIN.

  Patient problems: Pain

  MAUDE report 18185257 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #4. THE ARTICLE DESCRIBES A 74-YEAR-OLD MALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A KUGEL PATCH. THE ARTICLE NOTES THE PATIENT EXPERIENCED POST OPERATIVE COMPLICATIONS OF PERINEAL WOUND INFECTION, RECURRENT PERINEAL HERNIA, SEROMA, AND PAIN. THE SEROMA SPONTANEOUSLY RESOLVED WITHIN 3 MONTHS.

  Patient problems: Hernia; Pain; Post Operative Wound Infection; Seroma

  MAUDE report 18185254 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN (B)(6) 2010 AND (B)(6) 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #5. THE ARTICLE DESCRIBES ABOUT A 71-YEAR-OLD MALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A KUGEL PATCH. THE ARTICLE NOTES THE PATIENT EXPERIENCED POST OPERATIVE COMPLICATIONS OF RECURRENT PERINEAL HERNIA, SEROMA, AND DISCOMFORT. THE SEROMA SPONTANEOUSLY RESOLVED WITHIN 3 MONTHS.

  Patient problems: Discomfort; Hernia; Seroma

  MAUDE report 18185249 ↗
• InjuryAug 28, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  Attorney alleges that the patient underwent surgery for implant of an unspecified Bard/Davol Kugel Hernia Patch on (b)(6)2005. As reported, the patient is making a claim for an adverse patient outcome against the Kugel Hernia Patch. 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.Addendum per additional information provided:(b)(6)2005 ¿ Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of Kugel Patches (left - Device 1, right - Device 2). Per op notes, ¿In left groin, a small indirect defect was encountered. A Kugel Patch (Device 1) was sutured to coopers ligament with sutures and positioned over all defects. On right side, a small indirect sac was dissected free from cord. A small Kugel Patch (Device 2) was sutured to the cooper ligament using sutures.¿(b)(6)2022 ¿ Patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic repair with the removal of mesh (Device 1). Per op notes, ¿The left indirect inguinal hernia was noted. Several abdominal wall herniations

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

  MAUDE report 17630366 ↗
• InjuryFeb 9, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 16332913 ↗
• InjuryFeb 6, 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/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16303439 ↗
• InjuryFeb 3, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  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: Hernia; Insufficient Information; Pain

  MAUDE report 16294879 ↗
• InjuryDec 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR IN 2005 AND WAS IMPLANTED WITH PERFIX PLUG (DEVICE #1). REPORTEDLY, NINE YEARS POST IMPLANT (2014), THE PATIENT DEVELOPED A LEFT RECURRENT DIRECT HERNIA, AND UNDERWENT REPAIR WITH THE IMPLANT OF A KUGEL PATCH (DEVICE #2). AS REPORTED THE PATIENT DEVELOPED A RECURRENCE OF THE 2014 REPAIR AND ON (B)(6) 2022, UNDERWENT REPAIR AND WAS IMPLANTED WITH ANOTHER MESH.

  Patient problems: Hernia

  MAUDE report 15938690 ↗
• InjuryJun 28, 2022Defective 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/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Adhesion(s); Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 14839243 ↗
• InjuryMar 27, 2022Defective 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/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST KUGEL HERNIA PATCH. 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: Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 13925264 ↗