PROCEED PCDT1Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10705031047785), received between Nov 21, 2017 and Oct 30, 2025 — classified as 122 injuries.

The most frequently reported specific device problem is “Migration” (10 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 122 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 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 SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND ADHESION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 23431239 ↗
• InjuryJun 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) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL WOUND SEROMA OF THE PREVIOUSLY PLACED MESH ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR SURGERY OF INCARCERATED VENTRAL INCISIONAL HERNIA WITH PRIMARY DEFECT AND POLYPROPYLENE MESH ONLAY ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22280221 ↗
• InjuryMay 23, 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 AND HIATAL HERNIA ON (B)(6) 2011 WITH TWO (2) MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF INFECTED MESH AND FOREIGN BODIES ON (B)(6) 2015. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 22076057 ↗
• InjuryMay 14, 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) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCARCERATED VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA AND VOMITING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 22016433 ↗
• InjuryMay 14, 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) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCARCERATED VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA AND VOMITING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 22016428 ↗
• InjuryMar 11, 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) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21580205 ↗
• InjuryMar 3, 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) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LARGE ABDOMINAL PANNUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 21511140 ↗
• 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 INCISIONAL HERNIA ON (B)(6) 2009 WITH MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACUTE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21074168 ↗
• InjuryDec 17, 2024Adverse 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20951251 ↗
• InjuryDec 13, 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 VENTRAL HERNIA ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS ALONG THE ABDOMINAL WALL AND THERE WERE MULTIPLE BOWEL LOOPS ALONG THE ABDOMINAL WALL OBSCURING A LOT OF THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20924166 ↗
• InjuryDec 13, 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 VENTRAL HERNIA ON (B)(6) 2011 AND PROCEED WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS ALONG THE ABDOMINAL WALL AND THERE WERE MULTIPLE BOWEL LOOPS ALONG THE ABDOMINAL WALL OBSCURING A LOT OF THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20924162 ↗
• InjuryDec 13, 2024Adverse 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) 2016. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Fistula

  MAUDE report 20922558 ↗
• InjuryDec 12, 2024Adverse 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) 2016. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Fistula

  MAUDE report 20910969 ↗
• InjuryNov 29, 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 VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A DEBRIDEMENT AND CLOSURE OF OPEN ABDOMINAL WOUND ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY, RECURRENT HERNIA REPAIR SURGERY AND LYSIS OF ADHESIONS ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, MESH INFECTION, MID ABDOMINAL WALL SWELLING, ERYTHEMA, MILD CONSTIPATION, AND WOUND ABSCESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Constipation; Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20810240 ↗
• InjuryNov 29, 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 VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A DEBRIDEMENT AND CLOSURE OF OPEN ABDOMINAL WOUND ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY, RECURRENT HERNIA REPAIR SURGERY AND LYSIS OF ADHESIONS ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, MESH INFECTION, MID ABDOMINAL WALL SWELLING, ERYTHEMA, MILD CONSTIPATION, AND WOUND ABSCESS.

  Patient problems: Abscess; Adhesion(s); Constipation; Erythema; Hernia; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20810237 ↗
• InjuryNov 13, 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 ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL MESH SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE, PAIN, GAINED WEIGHT, CLEAR FLUID, AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Pain; Swelling/ Edema; Weight Changes

  MAUDE report 20679938 ↗
• InjuryNov 13, 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 ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL MESH SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE, PAIN, GAINED WEIGHT, CLEAR FLUID, AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Pain; Swelling/ Edema; Weight Changes

  MAUDE report 20679937 ↗
• InjuryNov 13, 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 ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL MESH SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE, PAIN, GAINED WEIGHT, CLEAR FLUID, AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Pain; Swelling/ Edema; Weight Changes

  MAUDE report 20679936 ↗
• InjuryNov 13, 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 ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL MESH SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGE, PAIN, GAINED WEIGHT, CLEAR FLUID, AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Pain; Swelling/ Edema; Weight Changes

  MAUDE report 20679935 ↗
• InjuryNov 12, 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 PROCEDURE ON (B)(6)2019 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6)/2021. IT WAS REPORTED THAT PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS AND INFECTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain; Unspecified Infection

  MAUDE report 20670607 ↗
• InjurySep 29, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE LYSIS OF ADHESION, SMALL BOWEL RESECTION WITH FUNCTIONAL END TO END ANASTOMOSIS, SUTURE OF SEROSITIS, TOTAL COLECTOMY WITH STAPLED ILEORECTAL ANASTOMOSIS ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED. THE MESH WAS SEVERELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL AND PERMANENTLY, THE SEROSA AND SUBSTANCE OF THE SMALL BOWEL. THERE WERE ALSO MULTIPLE INTERLOOP ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA, REPAIR OF ENTEROTOMY, LYSIS OF AND PLACEMENT OF DRAINS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL WOUND WITH PLACEMENT OF WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND EXPLORATION, MINI LAPAROTOMY, PLACEMENT OF BLAKE DRAIN AND ABSCESSES DEVELOPED ABOVE FASCIA REQUIRING REPLACEMENT OF VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF WOUND, PLACEMENT OF DRAIN IN THE ABDOMEN, DEBRIDEMENT OF FASCIA, PLACEMENT OF A NEW WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UND

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Erosion; Foreign Body Reaction; Hernia; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Vomiting

  MAUDE report 20330468 ↗
• InjurySep 28, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE LYSIS OF ADHESION, SMALL BOWEL RESECTION WITH FUNCTIONAL END TO END ANASTOMOSIS, SUTURE OF SEROSITIS, TOTAL COLECTOMY WITH STAPLED ILEORECTAL ANASTOMOSIS ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED THE MESH WAS SEVERELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL AND PERMANENTLY, THE SEROSA AND SUBSTANCE OF THE SMALL BOWEL. THERE WERE ALSO MULTIPLE INTERLOOP ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA, REPAIR OF ENTEROTOMY, LYSIS OF AND PLACEMENT OF DRAINS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL WOUND WITH PLACEMENT OF WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND EXPLORATION, MINI LAPAROTOMY, PLACEMENT OF BLAKE DRAIN AND ABSCESSES DEVELOPED ABOVE FASCIA REQUIRING REPLACEMENT OF VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF WOUND, PLACEMENT OF DRAIN IN THE ABDOMEN, DEBRIDEMENT OF FASCIA, PLACEMENT OF A NEW WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWEN

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Erosion; Foreign Body Reaction; Hernia; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Vomiting

  MAUDE report 20328856 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE LYSIS OF ADHESION, SMALL BOWEL RESECTION WITH FUNCTIONAL END TO END ANASTOMOSIS, SUTURE OF SEROSITIS, TOTAL COLECTOMY WITH STAPLED ILEORECTAL ANASTOMOSIS ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED THE MESH WAS SEVERELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL AND PERMANENTLY, THE SEROSA AND SUBSTANCE OF THE SMALL BOWEL. THERE WERE ALSO MULTIPLE INTERLOOP ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA, REPAIR OF ENTEROTOMY, LYSIS OF AND PLACEMENT OF DRAINS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL WOUND WITH PLACEMENT OF WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND EXPLORATION, MINI LAPAROTOMY, PLACEMENT OF BLAKE DRAIN AND ABSCESSES DEVELOPED ABOVE FASCIA REQUIRING REPLACEMENT OF VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF WOUND, PLACEMENT OF DRAIN IN THE ABDOMEN, DEBRIDEMENT OF FASCIA, PLACEMENT OF A NEW WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDE

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Erosion; Foreign Body Reaction; Hernia; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Vomiting

  MAUDE report 20328616 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE LYSIS OF ADHESION, SMALL BOWEL RESECTION WITH FUNCTIONAL END TO END ANASTOMOSIS, SUTURE OF SEROSITIS, TOTAL COLECTOMY WITH STAPLED ILEORECTAL ANASTOMOSIS ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED THE MESH WAS SEVERELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL AND PERMANENTLY, THE SEROSA AND SUBSTANCE OF THE SMALL BOWEL. THERE WERE ALSO MULTIPLE INTERLOOP ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA, REPAIR OF ENTEROTOMY, LYSIS OF AND PLACEMENT OF DRAINS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL WOUND WITH PLACEMENT OF WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND EXPLORATION, MINI LAPAROTOMY, PLACEMENT OF BLAKE DRAIN AND ABSCESSES DEVELOPED ABOVE FASCIA REQUIRING REPLACEMENT OF VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF WOUND, PLACEMENT OF DRAIN IN THE ABDOMEN, DEBRIDEMENT OF FASCIA, PLACEMENT OF A NEW WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDE

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Erosion; Foreign Body Reaction; Hernia; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Vomiting

  MAUDE report 20328615 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE LYSIS OF ADHESION, SMALL BOWEL RESECTION WITH FUNCTIONAL END TO END ANASTOMOSIS, SUTURE OF SEROSITIS, TOTAL COLECTOMY WITH STAPLED ILEORECTAL ANASTOMOSIS ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED THE MESH WAS SEVERELY ADHERENT TO MULTIPLE LOOPS OF SMALL BOWEL AND PERMANENTLY, THE SEROSA AND SUBSTANCE OF THE SMALL BOWEL. THERE WERE ALSO MULTIPLE INTERLOOP ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA, REPAIR OF ENTEROTOMY, LYSIS OF AND PLACEMENT OF DRAINS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL WOUND WITH PLACEMENT OF WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND EXPLORATION, MINI LAPAROTOMY, PLACEMENT OF BLAKE DRAIN AND ABSCESSES DEVELOPED ABOVE FASCIA REQUIRING REPLACEMENT OF VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF WOUND, PLACEMENT OF DRAIN IN THE ABDOMEN, DEBRIDEMENT OF FASCIA, PLACEMENT OF A NEW WOUND VAC ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWEN

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Erosion; Foreign Body Reaction; Hernia; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Vomiting

  MAUDE report 20328614 ↗

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