PROCEED PCDD1Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031047709), received between Nov 25, 2019 and Oct 15, 2025 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 42 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 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 AND A MESH WAS IMPLANTED ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23306737 ↗
• 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 THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND SMALL-BOWEL OBSTRUCTION. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY LAST (B)(6) 2014 AND TWO MESH WERE IMPLANTED. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 22699762 ↗
• 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 THE PATIENT UNDERWENT VENTRAL HERNIA SURGERY ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22699511 ↗
• InjuryFeb 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THAT IT WAS DISCOVERED THAT THE ENTIRE RIGHT SIDE OF HIS PREVIOUSLY PLACED MESH REPAIR HAD COMPLETELY PULLED APART FROM THE FASCIA. IT WAS REPORTED THAT THE PATIENT HAD A PARTIAL REMOVAL SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, VOMITING AND CONSTIPATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Constipation; Nausea; Vomiting

  MAUDE report 21430312 ↗
• InjuryFeb 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THAT IT WAS DISCOVERED THAT THE ENTIRE RIGHT SIDE OF HIS PREVIOUSLY PLACED MESH REPAIR HAD COMPLETELY PULLED APART FROM THE FASCIA. IT WAS REPORTED THAT THE PATIENT HAD A PARTIAL REMOVAL SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, VOMITING AND CONSTIPATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Nausea; Vomiting

  MAUDE report 21430308 ↗
• InjuryFeb 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 REPAIR ON (B)(4).2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21352876 ↗
• InjuryJan 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 REPAIR OF INCARCERATED INCISIONAL HERNIA ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA AND REMOVAL SURGERY OF PREVIOUSLY PLACED MESH ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21076555 ↗
• InjuryNov 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 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. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20704008 ↗
• InjuryNov 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 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. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20704007 ↗
• InjurySep 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 UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND HERNIA RECURRENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 20274414 ↗
• InjuryMar 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 REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE DEFECT CONTAINED INCARCERATED SMALL INTESTINE AND OMENTUM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2022 DURING WHICH THE SURGEON NOTED EXTENSIVE ADHESIONS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 18938011 ↗
• InjuryAug 14, 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 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. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15223028 ↗
• InjuryAug 14, 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 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. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15223027 ↗
• InjuryAug 14, 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 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. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15223026 ↗
• InjuryAug 5, 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 ON (B)(6) 2008, DUE TO A RECURRENT HERNIA AND ADHESIONS AND A SECOND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014, RECURRENT HERNIA, ADHESIONS, ABDOMINAL WALL ABSCESS, EDEMA AND INFECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED OTHER UNDISCLOSED ADVERSE EVENTS. IT WAS REPORTED THAT THE PATIENT HAD A MESH IMPLANTED ON (B)(6) 2008 WHICH WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15172640 ↗
• InjuryJul 27, 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) 2009 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, INFLAMMATION, HERNIA RECURRENCE AND ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15118120 ↗
• InjuryJul 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) 2018 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED IT HAD DETACHED ITSELF FROM THE LEFT ABDOMINAL WALL AND HAD BECOME BALLED UP IN A MASS OF OMENTUM AND SURGICAL TACKS NECESSITATING TOTAL EXPLANTATION OF THE MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED A SINUS TRACT ASSOCIATED WITH MESH IN ADDITIONAL INTRAABDOMINAL ADHESIONS. 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) 2009 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14973931 ↗
• InjuryJun 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) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTENSIVE ADHESIONS, ABDOMINAL WALL RECONSTRUCTION, SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14565803 ↗
• InjuryMar 23, 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 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 UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. 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) 2014 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13866314 ↗
• InjuryMar 23, 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 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 UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. 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 6/26/2014 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13866259 ↗
• InjuryFeb 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 13539258 ↗
• InjuryFeb 3, 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) 2012 DURING WHICH THE SURGEON NOTED IT DID HAVE ADHESIONS TO THE SMALL BOWEL WERE THE MESH WAS DENSELY ADHERED INTO THE SEROSA OF THE SMALL BOWEL IN SEVERAL PLACES. THE MASSIVE HERNIA DEFECT WAS FROM THE SYMPHYSIS PUBIS TO THE SCREEN AND THEN FROM ABOVE THE SCREEN ALL THE WAY ABOVE THE UMBILICUS. 12 DIFFERENT HERNIA DEFECTS IN THE ABDOMINAL WALL AND MASSIVE ADHESIONS, INTRAABDOMINAL ADHESIONS AS WELL AS SMALL BOWEL TO PERITONEUM AND SMALL BOWEL TO MARLEX SCREEN. THE SCREEN DID NOT APPEAR TO BE A MARLEX SCREEN, AND HAD DENSE SCAR TISSUE WHERE THE SCREEN WAS BUT WITH HUGE DEFECTS. LARGE AMOUNT OF OLD MESH WERE REMOVED AND NEW MESH PLACED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13447205 ↗
• InjurySep 8, 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 REVISION SURGERY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED AFTER LYSIS OF ADHESIONS FOR OVER 60 MINUTES, HE EXAMINED THE MESH AND NOTED THAT THE MESH AND ITS TACKS HAD BECOME ENTANGLED WITHIN THE ABDOMEN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, DENSE ADHESIONS, NAUSEA, BULGING, INFLAMMATION, STRESS AND ANXIETY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Inflammation; Nausea; Pain

  MAUDE report 12443768 ↗
• MalfunctionSep 8, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 THE MESH WAS USED. IT WAS REPORTED THAT THE BARCODE DID NOT HIT THE ¿GOOD ID¿ WHEN SCANNED. IT WAS ALSO REPORTED THAT WHEN THE BARCODE WAS SCANNED IT GAVE THE PHONE NUMBER BUT DID NOT GIVE THE EMAIL ADDRESS OR PRODUCT INFORMATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443448 ↗
• InjuryJun 1, 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED THE MESH HAD BECOME AFFIXED TO THE SEROSA OF THE BOWEL, WHICH REQUIRED EXTREME CARE TO REMOVE WITHOUT FURTHER INJURY. 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: Diarrhea; Nausea; Pain

  MAUDE report 11917403 ↗

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