PROCEED PCDL1Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031047747), received between Feb 5, 2018 and Dec 18, 2024 — classified as 30 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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

• InjuryDec 18, 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 HERNIA ON (B)(6) 2006 WITH MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2020 WITH MESH. DURING WHICH THE SURGEON NOTED EVIDENCE OF ADHESIONS BETWEEN THE OMENTUM AND THE PREVIOUS MESH AND THERE WAS INDICATION OF HERNIAL DEFECT BELOW PLACING OF THE PREVIOUS MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20960589 ↗
• InjuryOct 24, 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 OPEN REPAIR INCISIONAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE INCARCERATED LOOPS OF SMALL BOWEL. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RE-RECURRENT INCISIONAL HERNIA AND EXCISION OF OLD MESH ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE REPAIR SURGERIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20520116 ↗
• 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 HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED 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 6/1/2021. 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. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19915769 ↗
• InjuryJul 28, 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 A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2010. 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 15127024 ↗
• 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 HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED 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. 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 14190897 ↗
• 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 HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED 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. 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 14190896 ↗
• InjuryMar 10, 2022Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED HE FOUND MULTIPLE RECURRENT HERNIAS ALONG THE RIGHT AND LEFT SIDE OF THE PREVIOUSLY PLACED MESH. THE MESH HAD PULLED THROUGH THE SUTURES THROUGH THE FASCIA CAUSING MULTIPLE HERNIAS AROUND THE PREVIOUSLY PLACED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED THE MESH HAD BECOME INFECTED AND ERODED INTO THE SMALL INTESTINE. HE UNDERWENT EXTENSIVE AND METICULOUS LYSIS OF ADHESIONS TO EXPOSE THE MESH. MULTIPLE AREAS OF THE SMALL BOWEL NEEDED TO BE RESECTED AND THE ENTIRE INFECTED MESH WAS REMOVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND MOBILITY LIMITATIONS. 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 13727313 ↗
• InjuryMar 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 HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED DUE TO DEFECTS IN THE MESH, IT FAILED REQUIRING ADDITIONAL CARE AND TREATMENT. 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; Pain; Weight Changes

  MAUDE report 13657243 ↗
• InjuryFeb 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 HERNIA REPAIR SURGERY ON (B)(6) 2009 AND ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF A RECURRENT HERNIA, AND PARTIAL REMOVAL OF MESH ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13546497 ↗
• InjuryFeb 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 HERNIA REPAIR SURGERY ON (B)(6) 2009 AND ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF A RECURRENT HERNIA, AND PARTIAL REMOVAL OF MESH ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 13546496 ↗
• InjuryFeb 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 HERNIA REPAIR SURGERY ON (B)(6) 2009 AND ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF A RECURRENT HERNIA, AND PARTIAL REMOVAL OF MESH ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 13546495 ↗
• InjuryFeb 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) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13419654 ↗
• InjuryJan 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) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED THERE WAS PRESENCE OF OLD MESH WHICH WAS LOCATED INTRAPERITONEAL POSITION ALONG THE MIDLINE. THE MESH AND FASCIA WAS DIVIDED ALONG THE MIDLINE. THERE WERE EXTENSIVE ADHESIONS PRESENT, A LYSIS OF ADHESIONS WAS CARRIED OUT. THERE WAS A LOOP OF SMALL BOWEL THAT WAS RATHER DENSELY ADHERENT TO THE OLD MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Nausea; Pain

  MAUDE report 13350038 ↗
• InjurySep 13, 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, OPEN DRAINING WOUND, ABDOMINAL WALL RECONSTRUCTION AND DENSE ADHESIONS TO BOWEL AND MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Discomfort; Inflammation; Pain

  MAUDE report 12465537 ↗
• InjurySep 13, 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) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND CHRONIC PAIN/ DISCOMFORT, INFLAMMATION, OPEN DRAINING WOUND, ABDOMINAL WALL RECONSTRUCTION AND DENSE ADHESIONS TO BOWEL AND MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Discomfort; Inflammation; Pain

  MAUDE report 12465530 ↗
• InjuryMay 24, 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) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DENSE ADHESIONS TO BOWEL, SMALL BOWEL ADHERED TO MESH, SMALL TEAR TO THE BOWEL, DENSE ADHESIONS TO SMALL INTESTINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 11872901 ↗
• InjuryMay 3, 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) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, DENSE ADHESIONS, ADHESIONS TO MESH, BOWEL RESECTION AND SEROUS FLUID UNDER THE MESH. IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Inflammation; Pain

  MAUDE report 11767315 ↗
• InjuryMar 21, 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT SURGERY ON (B)(6) 2008 AND (B)(6) 2008 DURING WHICH THE SURGEON NOTED THE FASCIA HAD BROKEN DOWN AND THE MESH WAS EXPOSED TO THE INFECTION. THE MESH WOULD EVENTUALLY NEED TO BE REMOVED AS IT WAS EXPOSED TO THE CONTAMINATION OF THE ABDOMINAL WALL CELLULITIS AND ABSCESS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED TWO AREAS OF EXPOSED MESH AND EXCISED ALL EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT OF REMAINING MESH ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED DEBRIDED THE WOUND DOWN TO THE MUSCLE, CLEANED THE WOUND AND RESECTED THE REMAINING EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Cellulitis; Pain

  MAUDE report 11536983 ↗
• InjuryMar 21, 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT SURGERY ON (B)(6) 2008 AND (B)(6) 2008 DURING WHICH THE SURGEON NOTED THE FASCIA HAD BROKEN DOWN AND THE MESH WAS EXPOSED TO THE INFECTION. THE MESH WOULD EVENTUALLY NEED TO BE REMOVED AS IT WAS EXPOSED TO THE CONTAMINATION OF THE ABDOMINAL WALL CELLULITIS AND ABSCESS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED TWO AREAS OF EXPOSED MESH AND EXCISED ALL EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT OF REMAINING MESH ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED DEBRIDED THE WOUND DOWN TO THE MUSCLE, CLEANED THE WOUND AND RESECTED THE REMAINING EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Cellulitis; Pain

  MAUDE report 11536982 ↗
• InjuryMar 21, 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT SURGERY ON (B)(6) 2008 AND (B)(6) 2008 DURING WHICH THE SURGEON NOTED THE FASCIA HAD BROKEN DOWN AND THE MESH WAS EXPOSED TO THE INFECTION. THE MESH WOULD EVENTUALLY NEED TO BE REMOVED AS IT WAS EXPOSED TO THE CONTAMINATION OF THE ABDOMINAL WALL CELLULITIS AND ABSCESS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED TWO AREAS OF EXPOSED MESH AND EXCISED ALL EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT OF REMAINING MESH ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED DEBRIDED THE WOUND DOWN TO THE MUSCLE, CLEANED THE WOUND AND RESECTED THE REMAINING EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Inflammation; Pain

  MAUDE report 11536981 ↗
• InjuryMar 21, 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT SURGERY ON (B)(6) 2008 DURING WHICH THE SURGEON NOTED THE FASCIA HAD BROKEN DOWN AND THE MESH WAS EXPOSED TO THE INFECTION. THE MESH WOULD EVENTUALLY NEED TO BE REMOVED AS IT WAS EXPOSED TO THE CONTAMINATION OF THE ABDOMINAL WALL CELLULITIS AND ABSCESS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED TWO AREAS OF EXPOSED MESH AND EXCISED ALL EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT OF REMAINING MESH ON (B)(6) 2009 DURING WHICH THE SURGEON NOTED DEBRIDED THE WOUND DOWN TO THE MUSCLE, CLEANED THE WOUND AND RESECTED THE REMAINING EXPOSED MESH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Inflammation; Pain

  MAUDE report 11536980 ↗
• InjuryMar 18, 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) 2006 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 AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, ADHESIONS, AND ADHESIONS TO THE BOWEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11518594 ↗
• InjuryDec 15, 2020Adverse 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) 2016 DURING WHICH THE SURGEON NOTED HE FOUND THE MESH HAD MULTIPLE LOOPS OF BOWEL ADHERENT TO IT. HE PERFORMED EXTENSIVE LYSIS OF ADHESIONS. TWO SMALL SEROSAL TEARS IN LOOPS OF SMALL BOWEL OCCURRED, REQUIRING REPAIR. 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); Inflammation; Pain

  MAUDE report 11008686 ↗
• InjuryNov 10, 2020Adverse 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2016 DURING WHICH THE SURGEON NOTED THE MESH HAD SEPARATED FROM THE RIGHT LATERAL ASPECT OF THE HERNIA DEFECT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH SHRINKAGE, MESH SEPARATION, ADHESIONS, ABDOMINAL PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10816712 ↗
• InjurySep 15, 2020Adverse 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 REVISION SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2018 DURING WHICH THE SURGEON NOTED DENSE MESH ADHESIONS THAT REQUIRED INTENSIVE LYSIS. IT WAS DECIDED THAT IT WAS UNSAFE TO REMOVE THE MESH DUE TO THE INGROWTH. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation

  MAUDE report 10535224 ↗

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