PROCEED PCDM1Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 10705031047754), received between Dec 7, 2017 and Jan 26, 2026 — classified as 150 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 154 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COPIOUS ADHESIONS AND PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24182924 ↗
• InjuryAug 6, 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 EPIGASTRIC HERNIA REPAIR ON (B)(6) 2018 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22724428 ↗
• InjuryJul 18, 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 ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015 DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS THAT WERE TAKEN DOWN AND THE MESH WAS SEPARATED FROM THE POSTERIOR RECTUS AND WAS REMOVED WITH BOVIE CAUTERY AND ANOTHER MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED SIX INCHES OF SMALL BOWEL WAS RESECTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Nausea; Pain

  MAUDE report 22541630 ↗
• InjuryJun 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 VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT A REPAIR ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, LYSIS OF ADHESIONS. NO OTHER INFORMATION PROVIDED.

  Patient problems: Adhesion(s); Discomfort; Pain

  MAUDE report 22129675 ↗
• InjuryMay 26, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2015 AND TWO MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMED AREA ON THE ABDOMEN, PAIN AND DISCOMFORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Inflammation; Pain

  MAUDE report 22085203 ↗
• InjuryMay 20, 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 ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22057842 ↗
• InjuryMay 5, 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 ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21958888 ↗
• InjuryApr 27, 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 ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, ADHESIONS, SMALL BOWEL OBSTRUCTION, SMALL BOWEL RESECTION AND INCARCERATION OF THE MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2016. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21916139 ↗
• InjuryApr 22, 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 INCISIONAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL OF MESH ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21879125 ↗
• InjuryApr 21, 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 ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING THE HERNIA REPAIR SURGERY ON (B)(6) 2018. THE PATIENT EXPERIENCED SCARRING. IT WAS REPORTED THAT PATIENT HAS ANOTHER REVISION SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED DUE TO INCARCERATED HERNIA. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21878732 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21627826 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON 01/10/2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21135540 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 21099722 ↗
• InjuryDec 10, 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 PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NECROSIS, ADHESIONS AND CHRONIC ABDOMINAL PAIN.

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

  MAUDE report 20890757 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2012 DURING WHICH THE SURGEON NOTED THAT THE PATIENT HAD ADHESIONS ALONG ABDOMINAL WALL AND A BOWEL DENSELY ADHERENT TO THE MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20873533 ↗
• InjuryNov 5, 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 ON (B)(6) 2017 AND MESH WAS IMPLANTED AND DURING WHICH THE SURGEON NOTED HE RESECTED THE SAC AND PORTION OF THE OLD MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2021. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD A HERNIA REPAIR SURGERY ON (B)(6) 2016. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20607972 ↗
• InjuryNov 5, 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 ON (B)(6) 2017 AND MESH WAS IMPLANTED AND DURING WHICH THE SURGEON NOTED HE RESECTED THE SAC AND PORTION OF THE OLD MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2021. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD A HERNIA REPAIR SURGERY ON (B)(6) 2016. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20607839 ↗
• InjuryOct 8, 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 A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2014 THE SURGEON NOTED SOME OMENTAL ADHESIONS IN THE RIGHT SIDE OF ABDOMEN TO THE RIGHT SIDE OF PREVIOUSLY PLACED MESH LEFT SHE HAD SOME FASCIAL STAY SUTURE AND APPEARED ONE OF THESE HAD PULLED THROUGH LIKE IT WAS A SMALL SWISH CHEESE HERNIA CAUSING SMALL DEFECT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH MESH ON (B)(6) 2017 DURING WHICH MESH HAD TORN CAUSING A RECURRENCE IN THE MID PORTION OF THE MESH CONTAINING SMALL BOWEL AND PREPERITONEAL FAT. IT WAS REPORTED THAT THE PATIENT HAD LYSIS OF ADHESION, RECURRENT VENTRAL HERNIA REPAIR ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH MESH, INTRA ABDOMINAL ADHESIVE DISEASE, PARTIAL SMALL BOWEL OBSTRUCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT HAD NAUSEA, ABDOMINAL PAIN AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Nausea; Obstruction/Occlusion; Swelling/ Edema

  MAUDE report 20396642 ↗
• InjuryOct 8, 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 A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2014, THE SURGEON NOTED SOME OMENTAL ADHESIONS IN THE RIGHT SIDE OF ABDOMEN TO THE RIGHT SIDE OF PREVIOUSLY PLACED MESH LEFT SHE HAD SOME FASCIAL STAY SUTURE AND APPEARED ONE OF THESE HAD PULLED THROUGH LIKE IT WAS A SMALL SWISH CHEESE HERNIA CAUSING SMALL DEFECT.IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH MESH ON (B)(6) 2017 DURING WHICH MESH HAD TORN CAUSING A RECURRENCE IN THE MID PORTION OF THE MESH CONTAINING SMALL BOWEL AND PREPERITONEAL FAT. IT WAS REPORTED THAT THE PATIENT HAD LYSIS OF ADHESION, RECURRENT VENTRAL HERNIA REPAIR ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH MESH, INTRA ABDOMINAL ADHESIVE DISEASE, PARTIAL SMALL BOWEL OBSTRUCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT HAD NAUSEA, ABDOMINAL PAIN AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Nausea; Swelling/ Edema

  MAUDE report 20395291 ↗
• InjurySep 16, 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) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 AND REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20232690 ↗
• InjurySep 16, 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) /2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 AND REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20232071 ↗
• InjuryAug 26, 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 REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY AND LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESION TOGETHER WITH AN ABDOMINAL ANTERIOR RELEASE ON (B)(6) 2018 DURING WHICH SURGEON NOTED CLOSED LOOP OBSTRUCTION CONTAINING SMALL BOWEL SECONDARY TO MESH, LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND MESH REMOVAL ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL WOUND DEHISCENCE, EXTRACTION OF NECROTIC MESH AND WASHOUT OF THE WOUND ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Scar Tissue; Unspecified Infection

  MAUDE report 20064251 ↗
• InjuryAug 23, 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 REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY AND LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESION TOGETHER WITH AN ABDOMINAL ANTERIOR RELEASE ON (B)(6) 2018 DURING WHICH SURGEON NOTED CLOSED LOOP OBSTRUCTION CONTAINING SMALL BOWEL SECONDARY TO MESH, LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND MESH REMOVAL ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL WOUND DEHISCENCE, EXTRACTION OF NECROTIC MESH AND WASHOUT OF THE WOUND ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Necrosis; Scar Tissue; Unspecified Infection; Wound Dehiscence

  MAUDE report 20050750 ↗
• InjuryAug 23, 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 REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY AND LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESION TOGETHER WITH AN ABDOMINAL ANTERIOR RELEASE ON (B)(6) 2018 DURING WHICH SURGEON NOTED CLOSED LOOP OBSTRUCTION CONTAINING SMALL BOWEL SECONDARY TO MESH, LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND MESH REMOVAL ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL WOUND DEHISCENCE, EXTRACTION OF NECROTIC MESH AND WASHOUT OF THE WOUND ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20048068 ↗
• InjuryAug 22, 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 PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESIONS AND HERNIA RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED RECURRENT HERNIA, SCARRING, AND BLEEDING. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Scar Tissue

  MAUDE report 20035570 ↗

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