Parietex PCO3020OSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521179776), received between Oct 30, 2017 and Feb 2, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPEN INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE WITH PLACEMENT OF A MESH PROSTHESIS, THE PATIENT EXPERIENCED A PERMANENT INTERNAL BURNING SENSATION, PINCHING SENSATION, AND EPISODES OF VIOLENT PAIN. SINCE FEBRUARY 2024, THE PATIENT REPORTED CHRONIC FATIGUE, DIGESTIVE PAIN, GASTRIC REFLUX, PERMANENT DISCOMFORT IN THE THROAT, GASTROPARESIS, EARLY SATIETY, LACK OF APPETITE, CHEMICAL BODY ODOR, CHEMICAL SMELLY STOOLS, MENTAL FOG, ANXIETY-DEPRESSIVE DISORDER, DIFFICULTY CONCENTRATING, IRRITABILITY, HYPERTENSION, TACHYCARDIA, DIFFICULTY AND PAIN WHEN STANDING IN THE ABDOMEN, MUSCLE WEAKNESS, BALANCE DISORDER, DIZZINESS, DARK AND SMELLY URINE, SIGNIFICANT HAIR LOSS, DRY EYES, AND OCCASIONAL BLURRED VISION.

  Patient problems: Abdominal Pain; Anxiety; Balance Problems; Blurred Vision; Burning Sensation; Decreased Appetite; Depression; Discomfort; Dizziness; Dry Eye(s); Fatigue; Foreign Body Reaction; Hair Loss; Heartburn/Indigestion; High Blood Pressure/ Hypertension; Irritability; Tachycardia; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 24240050 ↗
• InjuryAug 20, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE, MESH MIGRATION, DEPRESSION, PAIN, ABSCESS, ADHESIONS, OPEN WOUND, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH, EXCISIONAL DEBRIDEMENT OF ABDOMINAL WALL, MESH REMOVAL, MESH REVISION, EXPLORATORY LAPAROTOMY, PARTIAL OMENTECTOMY, LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAM.

  Patient problems: Abscess; Adhesion(s); Depression; Distress; Hernia; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22856731 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CUSTOMER POST-OPERATIVELY ON AN UMBILICAL PROCEDURE, THERE WAS PAIN THROUGHOUT THE ABDOMEN AND RIBS. THE CUSTOMER WENT BACK TO THE SURGEON TWICE AND THE SURGEON EXPLAINED THAT IT WAS THE STAPLES THAT WERE GOING TO RESORB. SIX MONTHS LATER, STILL IN PAIN, THEN PAIN WHERE THERE WAS THE DISEMBOWELMENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE, AND EVERYTHING WAS FINE. MORE THAN A YEAR LATER, THE CUSTOMER WAS STILL IN PAIN AND HAD NOT RECOVERED FROM THE PREVIOUS SHAPE. THE PATIENT DID HAVE SESSIONS AT PHYSIOTHERAPY TO REMAIN ACTIVE AND PAINKILLERS WERE TAKEN BUT DOESN'T WANT TO GET USED TO IT.

  Patient problems: Pain; Unintended Radiation Exposure

  MAUDE report 22564401 ↗
• InjuryAug 20, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION DRAINAGE OF ABSCESS CAVITY, WOUND VAC PLACEMENT, PARTIAL MESH REMOVAL.

  Patient problems: Abscess; Unspecified Tissue Injury

  MAUDE report 20004174 ↗
• InjuryNov 8, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, OBSTRUCTION, AND INCARCERATION OF HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF TWO DRAINS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Dizziness; Hernia; Inflammation; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Pain; Perforation; Pulmonary Valve Insufficiency/ Regurgitation; Respiratory Insufficiency; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15753580 ↗
• InjuryAug 31, 2022Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND NECROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15331961 ↗
• InjuryJan 8, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, MESHOMA/BALLING, ABSCESS, CHRONIC DRAINING ABDOMINAL WOUND, SCAR TISSUE, EXPOSED MESH, UNINCORPORATED MESH, FIBROSED GRANULATION TISSUE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, DEBRIDEMENT, WOUND PACKED, AND INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Ascites; Fibrosis; Fistula; Fluid Discharge; Granuloma; Hematoma; Hernia; Impaired Healing; Inflammation; Purulent Discharge; Scar Tissue; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11138808 ↗
• InjuryNov 25, 2020Mechanics 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 PARASTOMAL AND VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL INVOLVEMENT, RECURRENCE, INFECTION, MESH FAILURE, DISCOMFORT, EMOTIONAL HARM, DRAINAGE, ABSCESS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, DRAIN ABSCESS, AND MEDICATION.

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

  MAUDE report 10907272 ↗
• InjuryApr 17, 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 INFECTION, RECURRENCE, ABSCESS, PAIN AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

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

  MAUDE report 9974180 ↗
• InjuryMar 26, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTED MESH, ABSCESS, FISTULA, AIR FLUID LEVEL IN ABDOMINAL WALL, OPEN WOUND, FIBROCONNECTIVE TISSUE/SKIN, PURULENT MATERIAL, MESH FREE FLOATING, AND PARTIALLY DEBRIDED AWAY, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ANTIBIOTICS, INCISION AND DRAINAGE OF ABSCESS, MESH PARTIALLY TRIMMED, REMOVAL OF NYLON SUTURE, WOUND PACKED, EXCISION OF MESH AND SUTURE, WASHOUT OF WOUND, DRAIN PLACED, CATHETER PLACED, AND TRANSFER TO THE ICU.

  Patient problems: Abscess; Adhesion(s); Ascites; Fistula; Impaired Healing; Injury; No Code Available; Purulent Discharge; Unspecified Infection

  MAUDE report 9883431 ↗
• InjuryMar 26, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTED MESH, ABSCESS, FISTULA, AIR FLUID LEVEL IN ABDOMINAL WALL, OPEN WOUND, FIBROCONNECTIVE TISSUE/SKIN, PURULENT MATERIAL, MESH FREE FLOATING, AND PARTIALLY DEBRIDED AWAY, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ANTIBIOTICS, INCISION AND DRAINAGE OF ABSCESS, MESH PARTIALLY TRIMMED, REMOVAL OF NYLON SUTURE, WOUND PACKED, EXCISION OF MESH AND SUTURE, WASHOUT OF WOUND, DRAIN PLACED, CATHETER PLACED, AND TRANSFER TO THE ICU.

  Patient problems: Abscess; Adhesion(s); Ascites; Fistula; Impaired Healing; Injury; No Code Available; Purulent Discharge; Unspecified Infection

  MAUDE report 9883428 ↗
• InjuryJan 2, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, ADHESIONS, SCARRING, ABDOMINAL WOUND, INFECTION, ABSCESS, MESHOMA, INFLAMMATORY PHLEGMON, ACCUMULATION OF FLUID, RECURRENT DRAINAGE FROM ABDOMINAL WALL INCISION, AND MESH INFECTED AND BALLED UP IN MANY AREAS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, DEBRIDEMENT, WOUND VAC PLACEMENT AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discharge; Emotional Changes; Fistula; Fluid Discharge; Impaired Healing; Inflammation; Injury; Pain; Scar Tissue; Scarring; Sore Throat; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9538349 ↗
• InjuryDec 13, 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 RECURRENT INCARCERATED INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE OF HERNIA, ADHESIONS, AND LARGE RIGHT UPPER QUADRANT BULGE ALONG SUBCOSTAL SCAR. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS AND REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Injury; Scarring

  MAUDE report 9465060 ↗
• InjuryDec 13, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH INFECTION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Bowel Burn; Hernia; Injury; Unspecified Infection

  MAUDE report 9464980 ↗
• InjuryOct 7, 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 RECURRENT INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, OPEN WOUND, SEVERE PAIN, HERNIA RECURRENCE, ADHESIONS, FIBROSIS, SCARRING, MESH WITH PORTIONS OF EDEMATOUS, CONGESTED, AND FIBROMEMBRANOUS TISSUE, ABDOMINAL ABSCESS, INFECTED AND DRAINING SINUSES WITH MINIMAL PURULENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, INFECTED MESH REMOVAL, WOUND VAC, AND ABDOMINAL WASHOUT.. THE PRODUCT HAD BEEN USED WITH AN UNKNOWN SECURESTRAP DEVICE.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discharge; Discomfort; Edema; Emotional Changes; Fibrosis; Hernia; Impaired Healing; Injury; Muscle Weakness/Atrophy; No Code Available; Pain; Purulent Discharge; Scar Tissue; Scarring; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9164396 ↗
• InjurySep 17, 2019Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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, RECURRENCE, PREVIOUS MESH HAD DROOPED, BOWEL WAS INTERPOSED BETWEEN THE MESH AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS. THE DEVICE WAS USED WITH AN UNKNOWN ABSORBATACKER.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Injury; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 9074211 ↗
• InjurySep 15, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER INLAY IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PREVIOUS MESH, LYSIS OF ADHESIONS AND PARTIAL OMENTECTOMY. THE DEVICE HAD BEEN USED WITH UNKNOWN PROTACS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Ascites; Constipation; Hernia; Injury; Nausea; Necrosis; Pain; Unspecified Tissue Injury

  MAUDE report 9067950 ↗
• InjuryJun 11, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; 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 AND A LEFT SPIGELIAN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, HARD MASS ATTACHED TO ABDOMINAL WALL AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF HERNIA WITH MESH USING ROBOTIC/LAPAROSCOPIC ASSISTED INCISIONAL HERNIA REPAIR AND ROBOTIC ASSISTED EXCISION OF PELVIC MASS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Erosion; Hernia; Injury; Necrosis; No Code Available; Nodule; Obstruction/Occlusion; Pain; Renal Failure; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 8687981 ↗
• InjuryMay 1, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT ABDOMINAL WALL HERNIAS, SEVERE PAIN, INFECTED MESH, OPEN WOUND, ABSCESS, BLOODY/FOUL-SMELLING DRAINAGE FROM THE INCISION AND SINUS TRACT. POST-OPERATIVE TREATMENT INCLUDED EXCISION/DEBRIDEMENT OF INFECTED MESH, WOUND VAC, AND MESH REMOVAL SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blood Loss; Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Ulcer; Ulceration; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8571652 ↗
• InjuryMar 29, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Perforation; 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 COMPLEX INCISIONAL HERNIA AND A LEFT-SIDED PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, ANASTOMOSIS OF LONGSTANDING ENTEROCUTANEOUS FISTULA AND EXCISION OF PREVIOUS MESH WITH PLACEMENT OF NEW MESH. THE DEVICE HAD BEEN USED WITH WOUND VAC. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Bowel Perforation; Erosion; Fistula; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; No Code Available; Pain; Perforation; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8465051 ↗
• InjuryOct 30, 2017Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVIC. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED ABDOMINAL MESH, RECURRENCE, ANTERO-MESH FLUID COLLECTION, HOSPITALIZATION FOR SEPSIS, MESH ROLLED ONTO ITSELF, SPONTANEOUS DRAINAGE AND PAIN FROM ABDOMINAL WOUND, DENSE ADHESIONS TO THE RECUTS MUSCULATURE AS WELL AS OMENTUM AND STOMACH BENEATH AND FOREIGN BODY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH EXCISION, CLOSURE OF ABDOMINAL WOUND, OPERATIVE EXPLORATION WITH SELECTIVE DEBRIDEMENT, RE-EXPLORATION OF ABDOMINAL WOUND, REMOVAL OF FOREIGN BODY, REPAIR OF INCISIONAL HERNIA, EVACUATION OF FLUID COLLECTION AND WOUND VAC.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Discharge; Hernia; Injury; No Code Available; Sepsis; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 6986864 ↗