PROCEED PCDB1Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705031047693), received between Jan 9, 2018 and Apr 20, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K060713); they may or may not involve this specific model.

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 54 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT SURGERY A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2021 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24925989 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESION AND HERNIA. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24719303 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY (B)(6) 2013 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Hernia; Pain

  MAUDE report 22290617 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)/2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6)2016. IT WAS REPORTED THAT THE PATIENT HAD SMALL BOWEL OBSTRUCTION, ADHESIONS, NAUSEA AND VOMITING. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 21301322 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6)2016. IT WAS REPORTED THAT THE PATIENT HAD SMALL BOWEL OBSTRUCTION, ADHESIONS, NAUSEA AND VOMITING. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 21301317 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED DUE TO THE PATIENT DEVELOPED A HERNIA JUST BELOW THE OLD MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED DUE TO SMALL BOWEL OBSTRUCTIONS SECONDARY TO ADHESIONS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND VOMITING. NO OTHER INFORMATION PROVIDED.

  Patient problems: Hernia; Nausea; Vomiting

  MAUDE report 21124303 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA AND REMOVAL SURGERY ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21074244 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19991235 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19991185 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19991158 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022. THE PATIENT EXPERIENCE ADHESIONS AND INCISIONAL HERNIA. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2008 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19916145 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 AND TWO PIECES OF MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED EXTENSIVE OMENTAL ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022 DURING WHICH THE SURGEON NOTED THE PATIENT HAD CHRONIC INFLAMMATION, A FOREIGN BODY REACTION AND A RECURRENT HERNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON 3/17/2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Foreign Body Reaction; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 18735944 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 AND TWO PIECES OF MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED EXTENSIVE OMENTAL ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022 DURING WHICH THE SURGEON NOTED THE PATIENT HAD CHRONIC INFLAMMATION, A FOREIGN BODY REACTION AND A RECURRENT HERNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON 3/17/2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Foreign Body Reaction; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 18735941 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 AND TWO PIECES OF MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED EXTENSIVE OMENTAL ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022 DURING WHICH THE SURGEON NOTED THE PATIENT HAD CHRONIC INFLAMMATION, A FOREIGN BODY REACTION AND A RECURRENT HERNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Foreign Body Reaction; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 18735939 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 15891936 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND HERNIA REPAIR SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, ADHESIONS, STRESS AND ANXIETY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Decreased Appetite; Hernia; Inflammation; Pain; Scar Tissue

  MAUDE report 15697780 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND HERNIA REPAIR SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, ADHESIONS, STRESS AND ANXIETY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain; Scar Tissue

  MAUDE report 15697779 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010 DUE TO ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain

  MAUDE report 15255713 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON 4/8/2019 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE MESH ON 1/15/2022. DURING THE PROCEDURE, THE SURGEON REPAIRED THE PATIENTS RECURRENT HERNIA WITH AN UNKNOWN ADDITIONAL PIECE OF HERNIA MESH. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14412469 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE MESH PRODUCTS ON (B)(6) 2019. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14384735 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE MESH PRODUCTS ON (B)(6) 2019. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14384494 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2008 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 14185504 ↗
• InjuryApr 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND CHRONIC PAIN AND DISCOMFORT, INFLAMMATION, ABDOMINAL WALL RECONSTRUCTION, SCARRING AND MESH INCARCERATED WITHIN THE HERNIA DEFECT AND STUCK TO PREPERITONEAL FAT AND TO THE PERITONEUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Discomfort; Hernia; Inflammation; Pain; Scar Tissue

  MAUDE report 14132484 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED THE MESH WAS DENSELY ADHERED TO THE OMENTUM AND COLON. HE DISSECTED THE MESH DOWN FROM THE ANTERIOR ABDOMINAL WALL MOBILIZATION OF THE SIGMOID COLON AND RECTUM WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 13577671 ↗
• InjuryNov 2, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT BILATERAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED IT WAS FOUND TO HAVE ADHERED AND FAILED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED IT WAS FOUND TO HAVE FAILED AND MIGRATED INTO THE HERNIA SAC. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 12741742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060713. One submission often covers many models, so check the product and lot details in each record.

• Z-0533-2021 · Oct 23, 2020 · Terminated
  PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
• Z-1329-2014 · Feb 19, 2014 · Open, Classified
  Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that r
• Z-0903-2011 · Oct 18, 2010 · Open, Classified
  PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the a