PROLENE PMHRecalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10705031049017), received between Apr 30, 2014 and Jun 26, 2026 — classified as 76 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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

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

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2014 AND MESH WAS IMPLANTED. THE PATIENT HAS HAD MANY PREVIOUS EPISODES OF DIVERTICULITIS SINCE (B)(6) 2023. A CT WITH CONTRAST WAS PERFORMED (B)(6) 2023 EVIDENCED TETHERING OF THE BOWEL, COLOCOLIC, COLOVESICAL AND COLOVAGINAL FISTULAS AND FAT-STRANDING AND ADHESIONS CAUSING SIGMOID STRICTURE. SINCE (B)(6) 2025, A FURTHER CT WITH CONTRAST SHOWED FURTHER NARROWING OF STRICTURE AND RECOMMENDATION TO EAT A VERY LOW RESIDUE DIET DUE TO RISK OF A TOTAL BOWEL OBSTRUCTION. A FURTHER SIGMOIDOSCOPY PERFORMED. SURGICAL INTERVENTION PLANNED DUE TO TETHERED BOWEL THAT'S IMPACTING GI FUNCTION AND DIETARY CHOICES DUE TO SEVERE COLIC CAUSING VASOVAGAL SYNCOPE AND DUE TO THE CT RESULTS AND DUE TO THE RISK OF TOTAL BOWEL OBSTRUCTION AND ILEUS DEMONSTRATED ON PLAIN ABDO FILM AND TWO INPATIENT ADMISSIONS. THE SURGEON WILL SHORTLY DECIDE WHICH TYPE OF STOMA SURGERY WILL PROVIDE THE BEST OUTCOME HAVING BALANCED SURGICAL RISKS DUE TO NEWLY DIAGNOSED HSD IN (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abdominal Pain; Adhesion(s); Fistula; Incontinence; Insufficient Information; Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 25636421 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SACRAL COLPOPEXY WITH POSTERIOR VAGINAL REPAIR, DIVISION OF ADHESIONS AND CYSTOSCOPY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IN 2013, PATIENT HAD MESH EROSION REQUIRING SURGICAL INTERVENTION AND ON THE (B)(6) 2013 PATIENT HAD AN ANTERIOR VAGINAL REPAIR WITH EXCISION OF MESH EROSION, CYSTOSCOPY AND SUPRAPUBIC CYSTOTOMY. IN 2023, THE PATIENT PRESENTED TO THE MESH CLINIC WITH A 3 YEAR HISTORY OF PV BLEEDING AND INFECTIONS THAT WAS AFFECTING HER QUALITY OF LIFE. ON (B)(6) 25 PATIENTS HAD AN EUA AND CYSTOSCOPY WHICH FOUND A 1CM TUNNEL TRACKING UP R SIDE OF THE VAGINA ANOTHER 2-3CM. NO MESH PALPABLE IN THIS, TINY SINUS NOTED AT TOP OF THE TUNNEL, NO OBVIOUS MESH OR SUTURE SEEN. MRI IN 2023 SHOWED INFLAMMATORY CHANGE AT THE DISTAL MESH AT THE LEVEL OF THE VAGINAL VAULT SUPPORTING MESH FAILURE/EXPOSURE AND THE ANTERIOR RECTAL WALL TETHERS TO THE DISTAL MESH VAGINAL VAULT ATTACHMENT. ON THE (B)(6) 25 PATIENTS REQUIRED AN EXAMINATION UNDER ANESTHESIA, VAGINAL EXCISION OF SACROCOLPOPEXY MESH, VAGINAL REVISION AND CYSTOURETHROSCOPY. DURING THIS SURGERY THEY FOUND AT THE VAGINAL VAULT A 2CM AREA OF EXPOSED MESH, WITH LARGE AMOUNT OF GRANULA

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection

  MAUDE report 24225380 ↗
• InjuryJun 24, 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 LEFT LOWER QUADRANT VENTRAL HERNIA REPAIR SURGERY (B)(6) 2010 AND MESH AND 2 (TWO) MESH WERE IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY AND MULTIPLE REVISIONARY SURGERIES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22312922 ↗
• InjuryMay 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 ON (B)(6) 2012 "AND MESH" WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22027181 ↗
• InjuryFeb 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 A HERNIA REPAIR ON (B)(6)2016 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED INJURY. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD A HERNIA REPAIR ON (B)(6)2015 -MESH WAS IMPLANTED, AND ON (B)(6)2016- MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21301619 ↗
• InjuryFeb 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 A HERNIA REPAIR ON (B)(6) 2016 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED INJURY. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD A HERNIA REPAIR ON (B)(6) 2015 -MESH WAS IMPLANTED, AND ON (B)(6) 2016- MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21301617 ↗
• InjuryJan 17, 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 RECURRENT VENTRAL HERNIA REPAIR ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2019 DURING WHICH THE SURGEON NOTED THAT THE ¿MESH WAS DENSELY ADHERENCE TO THE UNDERLYING TISSUE AND THERE WAS ANOTHER SEPARATE TYPES OF MESH UNDERNEATH THE ANTERIOR LAYER OF MESH, WHICH WAS EXPOSED AND REMOVED." IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 21175815 ↗
• 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 (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21135657 ↗
• 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 INGUINAL HERNIA ON (B)(6) 2014 WITH MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCARCERATED RIGHT INGUINAL HERNIA ON (B)(6) 2017 WITH MESH IMPLANT DURING WHICH THE SURGEON NOTED INCARCERATED OMENTUM IN A RECURRENT INDIRECT HERNIA. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND RIGHT GROIN BULGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain; Swelling/ Edema

  MAUDE report 21064448 ↗
• 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 REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE OLD MESH HAD PULLED AWAY FROM THE FASCIA AND ON ABOUT TWO THIRDS OF THE RIGHT SIDE OF THE HERNIA REPAIR. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2013 DURING WHICH THE SURGEON NOTED SHE HAD TWO PREVIOUSLY PLACED PIECES OF MESH THAT WERE IN THE OVERLAY POSITION ON TOP OF HER FACIA THAT HAVE SHRUNKEN AND ARE NOT PROVIDING AND FORM OR FUNCTION, THEREFORE THEY WERE EXCISED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UNDERGONE HERNIA REPAIR SURGERY ON (B)(6) 2007. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20608093 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108712 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108710 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108708 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108704 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108703 ↗
• InjuryAug 30, 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) 2005 AND WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009, (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AND SCROTAL CYST. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Inflammation

  MAUDE report 20108697 ↗
• 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 ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008, (B)(6) 2009, AND ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED THE HERNIA SAC WAS SEEN INFERIOR TO THE PREVIOUS MESH AND IT APPEARED THAT THE MESH HAS TORN. THE HERNIA SAC WAS THEN DISSECTED. THE PREVIOUS MESH WAS THEN STITCHED ON THE INFERIOR ASPECT TO THE PERIOSTEUM OF THE ILIAC CREST. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 19918949 ↗
• 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 ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008, (B)(6) 2009, AND ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED THE HERNIA SAC WAS SEEN INFERIOR TO THE PREVIOUS MESH AND IT APPEARED THAT THE MESH HAS TORN. THE HERNIA SAC WAS THEN DISSECTED. THE PREVIOUS MESH WAS THEN STITCHED ON THE INFERIOR ASPECT TO THE PERIOSTEUM OF THE ILIAC CREST. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 19918902 ↗
• 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 ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2008, (B)(6) 2009, AND ON (B)(6) 2011 DURING WHICH THE SURGEON NOTED THE HERNIA SAC WAS SEEN INFERIOR TO THE PREVIOUS MESH AND IT APPEARED THAT THE MESH HAS TORN. THE HERNIA SAC WAS THEN DISSECTED. THE PREVIOUS MESH WAS THEN STITCHED ON THE INFERIOR ASPECT TO THE PERIOSTEUM OF THE ILIAC CREST. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 19918765 ↗
• InjuryMar 15, 2023Adverse 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 PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16542688 ↗
• 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007. 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 REVISION SURGERY ON (B)(6) 2013 DUE TO ABDOMINAL ABSCESS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY, LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS AND PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED DENSE INTRA-ABDOMINAL ADHESIONS AND BOWEL EROSION RESULTING IN SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain; Scar Tissue

  MAUDE report 15664914 ↗
• 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007. 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 REVISION SURGERY ON (B)(6) 2013 DUE TO ABDOMINAL ABSCESS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY, LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS AND PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED DENSE INTRA-ABDOMINAL ADHESIONS AND BOWEL EROSION RESULTING IN SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain; Scar Tissue

  MAUDE report 15664907 ↗
• 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007. 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 REVISION SURGERY ON (B)(6) 2013 DUE TO ABDOMINAL ABSCESS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY, LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS AND PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED DENSE INTRA-ABDOMINAL ADHESIONS AND BOWEL EROSION RESULTING IN SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Erosion; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 15664889 ↗
• 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007. 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 REVISION SURGERY ON (B)(6) 2013 DUE TO ABDOMINAL ABSCESS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY, LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS AND PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED DENSE INTRA-ABDOMINAL ADHESIONS AND BOWEL EROSION RESULTING IN SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain; Scar Tissue

  MAUDE report 15664861 ↗
• 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) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007. 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 REVISION SURGERY ON (B)(6) 2013 DUE TO ABDOMINAL ABSCESS AND ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY, LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS AND PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED DENSE INTRA-ABDOMINAL ADHESIONS AND BOWEL EROSION RESULTING IN SMALL BOWEL OBSTRUCTION WITH SUBSEQUENT SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SCARRING, BULGING, LOSS OF APPETITE, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain; Scar Tissue

  MAUDE report 15664772 ↗