PROLENE PMLRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10705031049031), received between May 28, 2018 and Jul 31, 2025 — classified as 52 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT THEY UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2017. ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY AND MESH WAS IMPLANTED UNDER BOTH BREASTS DIRECTLY ON THE CHEST WALL. IN THE WEEKS, MONTHS AND YEARS FOLLOWING, THE PATIENT EXPERIENCED: ¿ CHRONIC PAIN AND TIGHTNESS IN THE CHEST ¿ DIFFICULTY BREATHING, ESPECIALLY AT REST OR WHILE SLEEPING. ¿ WEAKNESS AND UNUSUAL SENSATIONS IN THE RIGHT SIDE OF MY CHEST. ¿ SYSTEMIC SYMPTOMS INCLUDING FATIGUE, NAUSEA, AND HYPERSENSITIVITY. ¿ CHRONIC JOINT PAIN PARTICULARLY, NECK, SHOULDER, CHEST (ENTIRE RIBCAGE) AND BACK, DESPITE THESE ONGOING ISSUES, MY CONCERNS WERE REPEATEDLY DISMISSED AS PSYCHOLOGICAL IN NATURE. NO FOLLOW-UP IMAGING, REFERRALS, OR INVESTIGATION WERE OFFERED. MY ISSUES WERE MINIMISED AND I WAS TOLD IT WAS NOT THE MESH AND REMOVAL OF THE MESH WOULD MAKE NO DIFFERENCE. ON (B)(6) 2025, THE PATIENT TRAVELED TO THE US TO HAVE A MESH REMOVAL PROCEDURE. THE AMERICAN SURGEON FOUND THE RIGHT SIDED MESH WAS TIGHTLY ADHERED TO THE RIGHT CHEST WALL, CAUSING VISIBLE TISSUE DISRUPTION AND SUSPECTED INFECTION. IT TOOK MUCH EFFORT TO CUT IT OUT OF MY CHEST. HE WAS ASTOUNDED BY THE SIZE OF IT. IT HAS SINCE

  Patient problems: Breathing-related sleep disorder; Crushing Injury; Fatigue; Hypersensitivity/Allergic reaction; Nausea; Neck Pain; Pain; Unspecified Infection

  MAUDE report 22682700 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT THEY UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2017. ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY AND MESH WAS IMPLANTED UNDER BOTH BREASTS DIRECTLY ON THE CHEST WALL. IN THE WEEKS, MONTHS AND YEARS FOLLOWING, THE PATIENT EXPERIENCED: CHRONIC PAIN AND TIGHTNESS IN THE CHEST. DIFFICULTY BREATHING, ESPECIALLY AT REST OR WHILE SLEEPING. WEAKNESS AND UNUSUAL SENSATIONS IN THE RIGHT SIDE OF MY CHEST. SYSTEMIC SYMPTOMS INCLUDING FATIGUE, NAUSEA, AND HYPERSENSITIVITY. CHRONIC JOINT PAIN PARTICULARLY, NECK, SHOULDER, CHEST (ENTIRE RIBCAGE) AND BACK, DESPITE THESE ONGOING ISSUES, MY CONCERNS WERE REPEATEDLY DISMISSED AS PSYCHOLOGICAL IN NATURE. NO FOLLOW-UP IMAGING, REFERRALS, OR INVESTIGATION WERE OFFERED. MY ISSUES WERE MINIMISED AND I WAS TOLD IT WAS NOT THE MESH AND REMOVAL OF THE MESH WOULD MAKE NO DIFFERENCE . ON (B)(6) 2025, THE PATIENT TRAVELED TO THE US TO HAVE A MESH REMOVAL PROCEDURE. THE AMERICAN SURGEON FOUND THE RIGHT SIDED MESH WAS TIGHTLY ADHERED TO THE RIGHT CHEST WALL, CAUSING VISIBLE TISSUE DISRUPTION AND SUSPECTED INFECTION. IT TOOK MUCH EFFORT TO CUT IT OUT OF MY CHEST. HE WAS ASTOUNDED BY THE SIZE OF IT. IT HAS SINCE BEEN CON

  Patient problems: Breathing-related sleep disorder; Crushing Injury; Fatigue; Hypersensitivity/Allergic reaction; Nausea; Neck Pain; Pain; Unspecified Infection

  MAUDE report 22682699 ↗
• 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)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21352777 ↗
• 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 MESH WAS IMPLANTED. IT WAS REPORTED 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 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21301548 ↗
• 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 EXPLANT SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. DURING WHICH THE SURGEON NOTED ¿HE HERNIA DEFECT WAS THREE TIMES THE DIAMETER OF THE MESH. HE PERFORMED A LYSIS OF ADHESIONS AND EXPLANTED THE MESH.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA ENLARGEMENT, ADHESIONS, MESH FAILURE, ABDOMINAL PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 21301364 ↗
• 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 HERNIA REPAIR ON (B)(6) 2023 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20923658 ↗
• InjuryDec 9, 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 PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 20878103 ↗
• InjuryNov 7, 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 RECURRENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WITH MESH IMPLANTED. IT WAS REPORTED THAT PATIENCE EXPERIENCED CHRONIC ABDOMINAL PAIN, RECURRENCE VENTRAL HERNIA, ADHESIONS, AND SEROMA OF THE ABDOMINAL WALL. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 20627821 ↗
• InjurySep 26, 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/INCISIONAL HERNIA ON(B)(6)2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20308129 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON 4/13/2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT REP

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation; Post Operative Wound Infection

  MAUDE report 20113715 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON (B)(6) 2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT R

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation

  MAUDE report 20113714 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON (B)(6) 2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT R

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation

  MAUDE report 20113713 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON 4/13/2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT REP

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation

  MAUDE report 20113709 ↗
• InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I WAS IN MY KITCHEN SITTING ON THE SEAT OF MY DRIVE MEDICAL WALKER AND IT BROKE. THIS IS THE SECOND TIME I'VE HAD AN ISSUE WITH A DRIVE WALKER BREAKING IN EXACTLY THE SAME SPOT. THE FIRST TIME I WAS ABLE TO GRAB A HOLD OF THE COUNTER AND NOT FALL. THIS TIME I FELL TO THE FLOOR AND WAS INJURED. PARAMEDICS HAD TO COME AND GET ME UP. I HAVE A HUGE BRUISE ON MY ARM AND INTERNALLY I PULLED MUSCLES THAT HAVE BEEN PAINFUL THE ENTIRE WEEK. I DID CONTACT (B)(6) BECAUSE THE WALKER BROUGHT IN EXACTLY THE SAME SPOT BOTH TIMES. IT SEEMS AS THOUGH IF I HAVE HAD TWO WALKERS OUT OF FIVE THAT I'VE OWNED BREAK THAT THIS MUST BE A MAJOR ISSUE. I WAS FORTUNATE TO NOT BREAK A LIMB, OR HIT MY HEAD, BUT HAD I BEEN OUTSIDE OR ELSEWHERE I DON'T KNOW WHAT WOULD'VE HAPPENED. I THINK THAT NEEDS TO BE LOOKED INTO. I HAVE A PICTURE OF MY VISIBLE INJURIES AS WELL AS THE BROKEN WALKER IF YOU WOULD LIKE TO SEE IT. REF REPORT: MW5158894.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation; Post Operative Wound Infection

  MAUDE report 20113696 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON 4/13/2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) /2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT RE

  Patient problems: Abdominal Pain; Hernia; High Blood Pressure/ Hypertension; Inflammation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113695 ↗
• 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT HAD REMOVAL OF MESH, RECURRENT HERNIA, LYSIS OF PELVIC ADHESIONS, BILATERAL SALPINGO OOPHORECTOMY ON (B)(6) 2011 DURING WHICH SURGEON NOTED EXTENSIVE LYSIS OF ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN RECURRENT INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND WASHOUT OF WOUND DUE TO POST-OP WOUND INFECTION. PATIENT HAD RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2013. PATIENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2014. PATIENT UNDERWENT PRIMARY CLOSURE OF INCISIONAL HERNIAS, DRAINAGE OF INTRAABDOMINAL ABSCESS CLOSURE, PLACEMENT OF NEGATIVE SUCTION WOUND VAC DEVICE, WASHOUT OF THE ABSCESS CAVITY AND THE SUBCUTANEOUS TISSUE DUE TO INTRAABDOMINAL ABSCESS ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL RECURRENT VENTRAL HERNIA REPAIR, DEBRIDEMENT OF ABDOMINAL WALL AND CLOSURE OF A SEPARATE LEFT LATERAL VENTRAL HERNIA ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT UNDERWENT R

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; High Blood Pressure/ Hypertension; Inflammation

  MAUDE report 20113694 ↗
• InjuryNov 2, 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 PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 18062324 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD VM 10.20 IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain

  MAUDE report 17971019 ↗
• InjuryOct 19, 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 PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 17971014 ↗
• InjuryOct 19, 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 PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT LYSIS OF ADHESIONS AND COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17970948 ↗
• InjuryOct 18, 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 REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD SURGICAL PROCEDURE ON (B)(6) 2021 AND HAD LYSIS OF ADHESIONS AND COLONOSCOPY WITH POLYPECTOMY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT HAD A HERNIA PROCEDURE ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17962301 ↗
• MalfunctionMay 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND MESH WAS USED. PRE-OPERATIVELY, FOREIGN PARTICLE (HAIR) WAS FOUND ON THE MESH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992034 ↗
• MalfunctionMay 3, 2023Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND MESH WAS USED. IT WAS IDENTIFIED THAT THE DEVICE DOES NOT HAVE THE SECONDARY PACKAGING (CARDBOARD BOX) AND THAT THE IMPORT LABEL AND HOLOGRAM ARE MISSING. THEREFORE, IT IS LIKELY THAT THE DEVICE WAS NOT IMPORTED FROM A SOURCE RECOGNIZED BY J&J. THE DEVICE WAS USED DURING THE PROCEDURE WHICH WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860395 ↗
• 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) 2007 AND TWO MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON 1/10/2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14570838 ↗
• 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) 2007 AND TWO MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION AND GASTROINTESTINAL MALFUNCTION. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. 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 14570817 ↗