Parietex PCO6VP (UDI 10884521514157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 10884521514157), received between Sep 19, 2016 and Jul 8, 2026 — classified as 1 death, 179 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (82 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 205 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN, INFECTION, INFLAMMATION, FISTULA, SEROMA, PERFORATION, MESH EROSION, ABSCESS, CHRONIC DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, WOUND VAC PLACEMENT, MEDICATION, HERNIA REPAIR WITH, WOUND DEBRIDEMENT, & USE OF BLAKE DRAIN.

  Patient problems: Abscess; Adhesion(s); Erosion; Fistula; Fluid Discharge; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25752693 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PERFORATION, SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Perforation; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 24525455 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, SUFFERING, DIFFICULTY PASSING STOOL, COLDNESS, NUMBNESS, SWOLLEN STOMACH, ABNORMAL STOMACH SHAPE, DIABETES, ANXIETY, RASHES, LESS LIFE QUALITY, INFECTION, ABDOMINAL PAIN, GAS, BLOATING AND SEXUAL DYSFUNCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Alteration in Body Temperature; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Deformity/ Disfigurement; Emotional Changes; Flatus; Hernia; Numbness; Pain; Rash; Sexual Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24136709 ↗
• MalfunctionNov 28, 2025Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A SUPRAPUBIC HERNIA REPAIR, THE DEVICE WAS FOUND TO HAVE A CRACK OR DEFORMITY IN THE PLASTIC WOVEN WITHIN THE MESH, RESULTING IN THE MESH BEING UNABLE TO LIE FLAT DURING A SUPRAPUBIC HERNIA PROCEDURE USING AN OPEN OPERATIVE APPROACH. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670085 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 23293826 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN UMBILICAL HERNIA PROCEDURE, TWO MESH PRODUCTS, A VENTRAL PATCH 6.6CM AND A VENTRAL PATCH 8CM WERE FOUND TO BE DAMAGED IN THE OPERATING ROOM PRIOR TO USE. SPECIFICALLY BREAKING IF NOT UNFOLDED IN ONE GO. BOTH DEVICES WERE NEVER IMPLANTED AND THE APPEARANCE OF THE MESH WAS DESCRIBED AS NORMAL. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093260 ↗
• MalfunctionSep 6, 2025Difficult or Delayed Positioning; Product Quality Problem; Difficult or Delayed Positioning; Product Quality Problem

  IT WAS REPORTED THAT THE MESH FOLDED INSIDE THE ABDOMINAL CAVITY, RESULTING IN A LOSS OF ITS EXPLANATORY POWER DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987346 ↗
• InjuryJul 22, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, BULGE, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, HERNIA REPAIR.

  Patient problems: Abdominal Distention; Adhesion(s); Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22569726 ↗
• InjuryJun 30, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DISCOMFORT, RECURRENCE, PAIN, ADHESIONS, EMOTIONAL CHANGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22359339 ↗
• InjuryJun 26, 2025Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, FISTULA, INFECTION, MESH FAILURE, EMOTIONAL HARM, ABSCESS, MESH EXPULSION AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND HERNIA REPAIR.

  Patient problems: Abscess; Discomfort; Emotional Changes; Fistula; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22341372 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, INFECTION, RECURRENCE, SMALL BOWEL OBSTRUCTION, ABSCESS, NERVE PAIN CAUSED MISSED WORK, MASS IN NAVEL AREA, <(>&<)> LOST THE ABILITY TO BEND OR TWIST OR LIFE ANY WEIGHT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, <(>&<)> GABAPENTIN.

  Patient problems: Abscess; Adhesion(s); Distress; Hernia; Nodule; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22204375 ↗
• InjuryJun 11, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MIGRATE, PAIN, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AN HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 22185514 ↗
• MalfunctionMay 16, 2025Difficult or Delayed Positioning; Product Quality Problem; Difficult or Delayed Positioning; Product Quality Problem

  IT WAS REPORTED THAT DURING AN OPEN UMBILICAL HERNIA REPAIR, THE MESH WAS PLACED IN THE ABDOMEN AND ONE SIDE WAS FIXATED, BUT IT WOULD NOT LAY FLAT WHEN ATTEMPTING TO FIXATE ON OPPOSITE SIDE OF FLAPS. THE SURGEON CUT THE SUTURES ON ONE SIDE AND REMOVED THE MESH. UPON REMOVAL, THE SURGEON NOTED THAT THE MESH FELT LIKE THE BLUE RING WAS SOMEHOW INTERFERING WITH THE MESH FOLDING AND JUST DIDN¿T FEEL RIGHT, NECESSITATING ITS REPLACEMENT WITH A NEW ONE OF THE SAME SIZE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040434 ↗
• MalfunctionMar 12, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, IMMEDIATELY UPON OPENING THE PACKAGE, THE COMPOSITE FILM OF THE MESH WAS BROKEN, FLAKING OFF, AND FELL APART INSIDE THE PACKAGE. TO RESOLVE THE ISSUE, ANOTHER VENTRAL PATCH WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584622 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE, THE COMPOSITE (PCOVP) MESH WAS BEING PLACED WHEN SOME OF THE COMPOSITE FILM CAME OFF THE PRODUCT. THE MESH WAS DESCRIBED AS BLOODY AND DAMAGED AFTER ATTEMPTED USE. THE ISSUE WAS DETECTED DURING INSERTION INTO THE PATIENT. THE MESH WAS NOT CUT PRIOR TO IMPLANTATION, AND IT WAS NOT IMPLANTED IN A CONTAMINATED FIELD. THE MESH WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. NO ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065751 ↗
• MalfunctionOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN UMBILICAL HERNIA PROCEDURE, DURING INSERTION INTO PATIENT, THERE WAS AN UNKNOWN ISSUE. A NEW MESH FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20398564 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A VENTRAL HERNIA REPAIR WITH MESH PLACEMENT PROCEDURE, THE PATIENT WAS REQUIRED TO RETURN TO THE OPERATING ROOM (OR). IT WAS FOUND THAT THERE WERE MARKED OMENTAL AND BOWEL ADHESIONS TO THE MESH, RESULTING IN SYMPTOMATIC SMALL BOWEL OBSTRUCTION REQUIRING BOWEL RESECTION.

  Patient problems: Obstruction/Occlusion; Tissue Breakdown

  MAUDE report 19127989 ↗
• InjuryMar 26, 2024Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN,MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18980383 ↗
• InjuryMar 5, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN,MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18839755 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INCARCERATED HERNIA RECURRENCE, ADHESIONS, PAIN, AND TISSUE SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18804750 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, <(>&<)> GANGRENOUS INCARCERATED SMALL BOWEL PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, REVISION SURGERY, LYSIS OF ADHESIONS, FRENCH DRAIN PLACEMENT, ICU, <(>&<)> HOSPITALIZATION.

  Patient problems: Adhesion(s); Hernia; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 18451837 ↗
• InjuryNov 10, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, RECTUS DIASTASIS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR, RELEASE OF ADHESIONS, CLOSURE OF RECTUS DIASTASIS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18111927 ↗
• InjuryNov 2, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18059634 ↗
• InjuryOct 12, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, TAKE DOWN OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17923797 ↗
• InjuryOct 5, 2023Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCAR TISSUE, INFLAMMATION, DISCOMFORT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, & EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, ABDOMINAL WALL RECONSTRUCTION WITH COMPONENT SEPARATION.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17877334 ↗