Parietex PCO6VP (UDI 10884521165717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521165717), received between Aug 10, 2017 and Sep 13, 2024 — classified as 33 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING A BLIND UMBILICAL HERNIA PROCEDURE, IN THE INTRAPERITONEAL ONLAY MESH (IPOM) POSITION (PERITONEUM), THE MESH WAS WAVY OR UNEVEN. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC; A FIXATION DEVICE FROM ANOTHER MANUFACTURER WAS THEN USED TO FIX THE MESH. THIS RESULTED IN AN EXTENDED INCISION, AS THE SURGEON NEEDED A TROCAR INCISION. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE FASCIA WAS CLOSED WITH THE SUTURE.

  Patient problems: Laceration(s)

  MAUDE report 20217780 ↗
• InjuryMar 25, 2024Migration 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 RECURRENCE AND MESH CURLED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 18969028 ↗
• InjuryMar 15, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, SCAR TISSUE, ADHESIONS, INFECTION, BOWEL PROBLEMS, EMOTIONAL DISTRESS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR.

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

  MAUDE report 18916401 ↗
• InjuryMar 12, 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 MESH REVISION, REMOVAL OF MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 18888231 ↗
• InjuryJan 8, 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 AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18471990 ↗
• InjuryDec 11, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFECTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR.

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

  MAUDE report 18302836 ↗
• InjuryMay 8, 2023Adverse 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 PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND PARTIAL REMOVAL OF OLD MESH.

  Patient problems: Abdominal Pain; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16891832 ↗
• InjuryMay 4, 2022Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL ANGUISH, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 14283296 ↗
• InjuryAug 19, 2021Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, HERNIA RECURRENCE, INFECTION, CHRONIC PAIN, SCARRING, DISFIGUREMENT, PSYCHOLOGICAL AND EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF PHYSICAL, MENTAL, AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Deformity/ Disfigurement; Emotional Changes; Failure of Implant; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12342162 ↗
• InjuryJul 23, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED LACK OF MESH INCORPORATION, MESH PULLED AWAY, ADHESIONS, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND PARTIAL REMOVAL OF MESH.

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

  MAUDE report 12217923 ↗
• InjuryMay 18, 2021Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, SEROMA, HEMATOMA, FISTULA, CANNOT STAND FOR LONG PERIODS OF TIME, BULGING IN PUBIC AREA, CONSTIPATION, NOT ABLE TO EMPTY BLADDER, INFREQUENT URINATION, URGENT NEED TO URINATE, ERECTILE DYSFUNCTION, VERY LITTLE SEMEN DURING ORGASM, WEIGHT LIFTING RESTRICTIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND GUIDED SEROMA DRAINAGE, REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESHES, AND BILATERAL COMPONENT SEPARATION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Erectile Dysfunction; Fistula; Flatus; Hematoma; Hernia; Micturition Urgency; Pain; Seroma; Sexual Dysfunction; Unspecified Kidney or Urinary Problem; Unspecified Reproductive System or Breast Problem; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 11845928 ↗
• InjuryFeb 5, 2021Migration 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 BILATERAL INGUINAL HERNIAS BY LAPAROSCOPIC SURGERY AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTED MESH, RECURRENCE, AND MESH CONTRACTION INTO A BALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

  Patient problems: Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11285149 ↗
• InjuryDec 28, 2020Adverse 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, RECURRENCE, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fistula; Fluid Discharge; Hernia; Impaired Healing; Incontinence; Inflammation; Nodule; Obstruction/Occlusion; Pain; Seroma; Thrombosis/Thrombus; Unspecified Infection; Unspecified Respiratory Problem; Unspecified Tissue Injury

  MAUDE report 11083071 ↗
• InjuryNov 18, 2020Adverse 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CONTAMINATED MESH, ADHESIONS, INFECTION, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXPLANATION OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Discomfort; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10860255 ↗
• MalfunctionOct 9, 2020Loss of or Failure to Bond; Product Quality Problem; Loss of or Failure to Bond; Product Quality Problem

  ACCORDING TO THE REPORTER, ON AN OPEN UMBILICAL HERNIA PROCEDURE, WHEN THE MESH WAS PUT IN PLACE, THE DEPLOYMENT HAS BEEN DIFFICULT. THE MESH WAS FOUND TO BE DAMAGED. THE CIRCLE WAS DISTORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10657133 ↗
• InjuryJul 20, 2020Migration 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HYPERVASCULARITY, WADDED UP MESH, INFLAMMATION, PAIN, EDEMA, SWELLING, PURULENT MATERIAL, TENDERNESS, AND ABNORMAL FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND REMOVAL OF MESH.

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Swelling

  MAUDE report 10295460 ↗
• InjuryFeb 6, 2020Adverse 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 ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Injury

  MAUDE report 9675180 ↗
• InjuryDec 19, 2019Migration 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 AN INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MIGRATION, RECURRENCE, BULGING HERNIA SAC, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Hernia; Injury; Pain

  MAUDE report 9494612 ↗
• InjuryNov 13, 2019Mechanics 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 OPEN THERAPEUTIC TREATMENT OF AN INCISIONAL ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ADHESIONS, MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE/COMFORT/CONSORTIUM, DEFECTIVE DEVICE, FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Obstruction/Occlusion; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 9315807 ↗
• InjuryOct 16, 2019Adverse 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 RIGHT-SIDE INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, FIBROADIPOSE CONNECTIVE TISSUE, FOREIGN BODY REACTION, AND MESH DENSELY ADHERED TO THE BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDES REVISION SURGERY, HERNIA REPAIR, ADHESIOLYSIS, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Foreign Body In Patient; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9199537 ↗
• MalfunctionSep 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON AN OPEN UMBILICAL HERNIA REPAIR, WHEN THE DEVICE WAS INSERTED IN THE PRE-PERITONEAL SPACE, IT WAS NOTED THAT THE DEVICE WAS DAMAGED. THE MESH WAS FOLDED IN TWO ORIENTATIONS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9029486 ↗
• InjurySep 2, 2019Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INCARCERATED HERNIA, MESH MIGRATION, PAIN, NAUSEA, VOMITING, SMALL BOWEL OBSTRUCTION, RECURRENT HERNIA DUE TO FAILURE OF MESH, ADHESIONS, MESH WAS BALLED UP AND MESH CONTRACTED WHICH HAD PULLED AWAY FROM FASCIA, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, CT SCAN, REMOVAL SURGERY, EXPLORATORY LAPAROTOMY WITH PARTIAL OMENTECTOMY, EXCISION OF OLD MESH, INCISIONAL HERNIA REPAIR, PLACEMENT OF NEW PHASIX MESH, DEBRIDEMENT OF WALL MUSCLES/SKIN/SUBCUTANEOUS TISSUE/FASCIA, LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED VENTRAL HERNIA WITH MESH IN MARCAINE BLOCK, BILATERAL V-Y MUSCLE ADVANCEMENT FLAPS AND COMPLEX CLOSURE.

  Patient problems: Abdominal Pain; Adhesion(s); Failure of Implant; Hernia; Injury; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 8954068 ↗
• MalfunctionJul 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING INSERTION INTO PATIENT ON AN OPEN REPAIR INCARCERATED HERNIA, THE DEVICE HAD CRACKED RING AND WAS NOT FITTING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811585 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 UNDERLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, IMPLANTATION OF MESH, AND REMOVAL OR MESH.

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

  MAUDE report 8687410 ↗
• InjuryApr 18, 2019Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN ABDOMINAL WALL ABSCESS, WHITE-TAN PURULENCE IN ABSCESS CAVITY, ERYTHEMA, AND SWELLING. POST-OPERATIVE TREATMENT INCLUDED INCISION/DRAINAGE OF LARGE ABDOMINAL WALL ABSCESS, WOUND IRRIGATION, AND PLACEMENT OF A WOUND VAC.

  Patient problems: Abscess; Erythema; Injury; Purulent Discharge; Swelling

  MAUDE report 8527169 ↗