PROCEED PCDW1Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031047792), received between May 9, 2018 and Aug 28, 2025 — classified as 43 injuries.

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

• InjuryAug 28, 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 REVISION SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT VENTRAL LAPAROSCOPIC HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22912788 ↗
• 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 REMOVAL SURGERY ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2013. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD INCISIONAL HERNIA REPAIR ON (B)(6) 2003 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL WALL ABSCESS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 22734791 ↗
• InjuryAug 4, 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 REVISION SURGERY ON (B)(6) 2013 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22697013 ↗
• InjuryAug 1, 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 REVISION SURGERY ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT VENTRAL LAPAROSCOPIC HERNIA REPAIR SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER HERNIA REPAIR SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22689233 ↗
• InjuryDec 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 LARGE VENTRAL INCISIONAL HERNIA ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2019 DURING WHICH THE SURGEON NOTED DRAINING SINUS TRACT WITH CONNECTION TO THE INFECTED MESH AND A SMALL AMOUNT OF PURULENT FLUID INSIDE THE ABDOMEN WHERE THE SMALL BOWEL WAS SIGNIFICANTLY ADHERED TO THE MESH. THERE WAS A SMALL AREA WHERE THE MESH WAS SOMEWHAT FOLDED ON ITSELF AND A POCKET WITH DARK BROWN FLUID. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 21001431 ↗
• 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 HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20661741 ↗
• 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 HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20661730 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2012. 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 UNDERWENT REVISION ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CELLULITIS, REDNESS, WARMTH, AND PAIN AT HER PANNICULECTOMY SITE, ELEVATED WHITE BLOOD CELL COUNT AND DEMONSTRATED A SEROMA. REVEALED SEROSANGUINEOUS FLUID. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Pain; Seroma

  MAUDE report 20086038 ↗
• InjuryAug 28, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2009 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS, COLON, AND SMALL BOWEL WITH HERNIA SAC. IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION OF INTERNAL HERNIA, LYSIS OF ADHESIONS, DEBRIDEMENT OF OLD MESH AND PRIMARY HERNIA REPAIR WITH RETENTION SUTURES ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED MULTIPLE LOOPS OF DILATED SMALL BOWEL AND LOOPS OF DECOMPRESS SMALL BOWEL AS WELL AS OMENTUM, ALL INCARCERATED AND ADHERED TO THE HERNIA SAC. THERE WAS MESH DENSELY ADHERENT TO THE SUPERIOR SURFACE OF THE HERNIAL FASCIAL DEFECT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, NAUSEA, VOMITING, CONSTIPATION, RECURRENT ABDOMINAL SEROMA, INFECTION AND CHOLECYSTECTOMY. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST (B)(6) 2008 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Constipation; Discomfort; Hernia; Nausea; Obstruction/Occlusion; Seroma; Unspecified Infection; Vomiting

  MAUDE report 20085418 ↗
• InjuryAug 21, 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20020039 ↗
• InjuryMay 20, 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 DUE TO RECURRENT HERNIA AND ADHESION. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19356175 ↗
• InjuryNov 6, 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) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015 DURING WHICH THE SURGEON NOTED HE FOUND CHRONICALLY INCARCERATED OMENTUM THAT WAS DENSELY ADHERENT TO THE SURROUNDING TISSUES. ONCE THEY HAD CIRCUMFERENTIALLY DISSECTED THIS OUT AND OPENED UP THE OLD MESH, MAKING 1 OPENING, THEY CAREFULLY DISSECTED OUT OF THE OMENTUM FROM ITS CHRONIC INCARCERATION. THEY ENCOUNTERED ANOTHER LAYER OF VERY SCARRED IN MESH THAT HAD FALLEN DOWN AWAY FROM THE FASCIA AND WAS COMPLETELY SEPARATE FROM ANY OTHER STRUCTURE ASIDE FROM THE OMENTUM, WHICH WAS ENCASED WITHIN. THIS REQUIRED A VERY EXTENSIVE AND TIME CONSUMING DISSECTION THAT AS WELL OVER 3 TIMES THE EXPECTED AMOUNT OF TIME TO PERFORM THIS PROCEDURE. THEY THEN VERY CAREFULLY DISSECTED AWAY ADHESIONS TO THE FASCIA. THIS INCLUDED OMENTUM, COLON AND SMALL BOWEL. THERE WERE SEVERAL ADHESIVE BANDS AND 1 VERY DENSE ADHESION OF THE TERMINAL ILEUM TO THE RIGHT LOWER QUADRANT ABDOMINAL WALL, MOST LIKELY FROM HER HERNIA REPAIR THAT SEVERELY NARROWED THE LUMEN OF THE SMALL BOWEL. THE COLON WAS THEN CAREFULLY DISSECTED F

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

  MAUDE report 15741616 ↗
• InjuryOct 30, 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) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY, HERNIA REPAIR SURGERY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, 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 15697713 ↗
• InjuryOct 25, 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) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED HE HAD CENTRAL MESH FAILURE WITH VISIBLE SMALL BOWEL ALTHOUGH HE HAD WHAT APPEARED TO BE CHRONIC STRICTURE THAT FELT NECESSITATED SHORT SEGMENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND DEBRIDEMENT AND WOUND VAC PLACEMENT ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, INFECTION, SMALL BOWEL RESECTION AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Unspecified Infection; Weight Changes

  MAUDE report 15671445 ↗
• InjuryAug 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 REVISION SURGERY ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED THE MESH WAS REVISED DUE TO EXTREME LEFT UPPER QUADRANT PAIN. DENSE OMENTAL TRAVERSE COLON AND MESOCOLIC ADHESIONS TO THE MESH WERE FOUND DURING THE OPERATION. SUBTLE SEPARATION OF THE MESH WAS ALSO DIAGNOSED. ANTERIOR CUTANEOUS NERVE ENTRAPMENT SYNDROME WAS DIAGNOSED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Inflammation; Pain

  MAUDE report 15246646 ↗
• InjuryAug 15, 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. 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 HAD A MESH IMPLANTED ON (B)(6) 2008 WHICH WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 15230395 ↗
• InjuryAug 15, 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. 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 HAD A MESH IMPLANTED ON (B)(6) 2008 WHICH WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 15230365 ↗
• InjuryAug 2, 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 AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, DIARRHEA, CHILLS, AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Inflammation; Nausea; Pain

  MAUDE report 15154012 ↗
• InjuryAug 2, 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 AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, DIARRHEA, CHILLS, AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Inflammation; Nausea; Pain

  MAUDE report 15154011 ↗
• InjuryApr 20, 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS AND A HERNIA RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 DURING WHICH A WOUND VAC WAS PLACED. 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: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 14164866 ↗
• InjuryApr 20, 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS AND A HERNIA RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 DURING WHICH A WOUND VAC WAS PLACED. 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: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 14164864 ↗
• InjuryApr 20, 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS AND A HERNIA RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 DURING WHICH A WOUND VAC WAS PLACED. 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: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 14164863 ↗
• InjuryMar 10, 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 AND REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE SURGEON NOTED THE MESH WAS INFECTED AND HAD BECOME ADHERENT TO SEVERAL LOOPS OF THE SMALL BOWEL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, FISTULA, CHRONIC ABDOMINAL WOUNDS AND EXTENSIVE LYSIS OF ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Pain; Unspecified Infection

  MAUDE report 13727587 ↗
• InjuryMar 9, 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) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNKNOWN DATE DURING WHICH THE SURGEON NOTED DUE TO DEFECTS IN THE MESH, IT FAILED. 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: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain; Weight Changes

  MAUDE report 13716812 ↗
• InjuryAug 10, 2021Adverse 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. 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. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2011 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 12302388 ↗

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