Parietex TEC1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521180260), received between Sep 22, 2017 and Mar 19, 2026 — classified as 43 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (12 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A MESH DURING A PROCEDURE FOR CURE OF EVENTRATION IN THE RIGHT ILIAC FOSSA, WHEREIN EVENTRATION WITH A TWO-CENTIMETER NECK WAS CONFIRMED BY ULTRASOUND. OVER THE COURSE OF SEVERAL MONTHS, THE PATIENT'S CONDITION DETERIORATED, RESULTING IN WALKING DIFFICULTIES, A FEELING OF HEAVINESS AND DIFFUSE PAIN IN THE STOMACH, TINGLING IN THE LIMBS, TREMORS, AND WEAKNESS IN THE LEGS. THE SURGEON NOTED THERE COULD BE A DELETERIOUS EFFECT DUE TO DIFFUSION OF TOXIC TOXINS FROM THE IMPLANTEDMATERIAL.

  Patient problems: Hernia; Muscle Weakness/Atrophy; Pain; Shaking/Tremors

  MAUDE report 24638325 ↗
• InjuryMar 19, 2025Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH SHRINKAGE, MESH FAILURE, PAIN, RECURRENCE, ADHESIONS, BULGING, AND TENDERNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21648777 ↗
• InjuryMar 5, 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, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 21532273 ↗
• InjuryMar 5, 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, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 21532270 ↗
• InjurySep 16, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE & PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 20226202 ↗
• InjuryNov 30, 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 RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 15890802 ↗
• InjuryOct 5, 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, SMALL BOWEL OBSTRUCTION, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND SMALL BOWEL RESECTION.

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

  MAUDE report 15546712 ↗
• InjuryOct 5, 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, SMALL BOWEL OBSTRUCTION, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, <(>&<)> SMALL BOWEL RESECTION.

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

  MAUDE report 15546547 ↗
• InjuryNov 19, 2021Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, NON-HEALING WOUND, DRAINAGE, OPEN WOUND, INFLAMMATION, ADHESIONS, UNINCORPORATED MESH, PAIN, STAPH, INFLAMED GRANULATION TISSUE, FIBROSIS, LESIONS, REDNESS/ERYTHEMA, TENDERNESS, CELLULITIS, SCAR, FOLLICULITIS, INGROWN HAIR, RIGHT GROIN CYST, BLOODY DRAINAGE, PROTRUSION OF TISSUE, GRANULOMA, FLUID COLLECTIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, REMOVAL OF MESH, ANTIBIOTICS, INGROWN HAIR REMOVAL, PACK WOUND, INCISION AND DRAINAGE OF RIGHT GROIN CYST, WOUND CARE, RIGHT GROIN EXPLORATION, ELECTROCAUTERY, EXCESSIVE GRANULATING TISSUE EXCISED.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cellulitis; Cyst(s); Discomfort; Erythema; Fibrosis; Fluid Discharge; Granuloma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12847085 ↗
• InjuryJul 8, 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 UMBILICAL HERNIA AND AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABDOMINAL PAIN, DISCOMFORT, TENDERNESS, NAUSEA, CONSTIPATION, DIFFICULTY URINATING, RIGHT GROIN MASS, AND GROIN PAIN.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Hernia; Nausea; Nodule; Pain; Unspecified Gastrointestinal Problem; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 12135553 ↗
• InjuryMay 13, 2021Migration 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 BALLED UP MESH, INFECTION, PAIN, MESH MIGRATION, SCAR TISSUE, FIBROFATTY TISSUE, INFLAMMATION, GRANULOMATOUS (FOREIGN BODY) LESIONS, STAPHYLOCOCCUS AUREUS, METHICILLIN SUSCEPTIBLE, PURULENT DRAINAGE, SCAR TISSUE, ADHESIONS, OPEN WOUND, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLANT OF MESH, DEBRIDEMENT OF SCAR TISSUE, REMOVAL OF SUTURES, SCAR TISSUE EXCISED, OPEN WOUND PACKED, AND INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Foreign Body Reaction; Granuloma; Impaired Healing; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11821251 ↗
• InjuryMar 25, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, INFECTED MESH, RECURRENCE, FIBROADIPOSE TISSUE WITH AREAS OF DENSE FIBROSIS, SUTURE GRANULOMA, FOREIGN BODY GIANT CELL REACTION, SINUS TRACT, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF VISIBLE SUTURES, HERNIA REPAIR WITH NEW MESH, ABDOMINAL WALL RECONSTRUCTION, AND DEBRIDEMENT OF ABDOMINAL WALL SUTURE GRANULOMA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fibrosis; Foreign Body Reaction; Granuloma; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11572146 ↗
• InjuryJan 7, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATION, GRANULATION TISSUE, NERVE DAMAGE, AND FIBROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND NEURECTOMY.

  Patient problems: Fibrosis; Hernia; Inflammation; Nerve Damage; Unspecified Tissue Injury

  MAUDE report 11135293 ↗
• InjuryDec 8, 2020Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEPARATION OF MATERIAL LAYERS, ADHESIONS, FISTULA, RECURRENCE, ABSCESS, FIBROADIPOSE TISSUE, GRANULATION TISSUE, FOREIGN BODY REACTION, INFLAMMATION, HEMORRHAGE, HISTIOCYTIC REACTION, PAIN, BULGE, LOOSE MESH, LACK OF INCORPORATION, DRAINAGE, SINUS TRACT, PURULENT MATERIAL, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF SUTURE MATERIAL, HERNIA REPAIR WITH NEW MESH, EXCISION OF INFECTED FOREIGN BODY (CONTAMINATED PROSTHETIC MESH) & MEDICATION.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10971898 ↗
• InjurySep 18, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10557124 ↗
• InjuryAug 21, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, INFLAMMATION, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, PARTIAL REMOVAL OF OLD MESH.

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

  MAUDE report 10439852 ↗
• InjuryJul 22, 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 THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, RECURRENCE, INFECTION AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

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

  MAUDE report 10310385 ↗
• InjuryJul 22, 2020Migration 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, RECURRENCE, INFECTION AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Fistula; Hernia; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10310353 ↗
• InjuryFeb 28, 2020Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, THICK WALLED FLUID AND GAS, PAUCICELLULAR, HYALINIZED, FIBROUS TISSUE WITH POSSIBLE DEGENERATION, DENSE FIBROCONNECTIVE TISSUE, FOREIGN BODY REACTION, STAPHYLOCOCCUS AUREUS, RECURRENT POSTOPERATIVE SEROMA, ABDOMINAL WALL FLUID COLLECTION, CLOUDY YELLOW FLUID, LARGE LOWER ABDOMINAL ABSCESS, CHRONIC NON-HEALING ABDOMINAL WOUND, HERNIA RECURRENCE, ENDOMETRIOSIS, DIASTASIS, LARGE VOLUME ASCITES, INCARCERATED BOWEL, DENSE MOUND OF SCAR TISSUE, PURULENT MATERIAL, PELVIC PAIN, OVARIAN CYST, ASPIRATION OF FLUID, VISCERATED BOWEL AND MESH THAT RETRACTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED TRANSVERSUS ABDOMINIS PLANE BLOCK, PREPERITONEAL, FLAP, DIAGNOSTIC LAPAROSCOPY ROBOTIC WITH EXTENSIVE LYSIS OF DENSE ADHESIONS, REVISION SURGERY, INCISION, DRAINAGE AND DEBRIDEMENT OF ABSCESS, PLACEMENT OF PACKING, ULTRASOUND GUIDED PLACEMENT OF PIGTAIL CATHETER IN ANTERIOR ABDOMINAL WALL FLUID COLLECTION, DIAGNOSTIC LAPAROSCOPY, ROBOTIC ASSISTED LAP VENTRAL INCISIONAL HERNIA REPAIR INTRAP

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cyst(s); Fibrosis; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Sexual Dysfunction; Staphylococcus Aureus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9770903 ↗
• InjuryFeb 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, PAIN, SCARRING, DISFIGUREMENT, ABDOMINAL PAIN, RECURRENCE, ADHESIONS AND ISCHEMIC CHANGES TO BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, MULTIPLE REVISION SURGERIES, BILATERAL RECTUS MUSCLE MYOFASCIAL RELEASES, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Deformity/ Disfigurement; Hernia; Injury; Ischemia; Nausea; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 9770349 ↗
• InjuryJan 24, 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 DENSE ADHESIONS OF BOWEL TO MESH, INCARCERATED HERNIA, RECURRENCE, FIBROUS ADHESIONS, FOREIGN BODY TYPE CELL REACTION, HEMATOMA, PAIN, OBSTRUCTION, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION WITH ANASTOMOSIS, DRAINAGE OF HEMATOMA, LYSIS OF ADHESIONS, ADMITTED TO HOSPITAL, OPEN REPAIR OF VENTRAL HERNIA, ENTEROLYSIS, DEBRIDEMENT OF ABDOMINAL FASCIA, IRRIGATION OF PERITONEAL CAVITY AND SUBCUTANEOUS TISSUES, AND REMOVAL SURGERY.

  Patient problems: Adhesion(s); Discomfort; Fibrosis; Fistula; Foreign Body Reaction; Hematoma; Hernia; Injury; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9628490 ↗
• InjuryJan 21, 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 HERNIA RECURRENCE AS WELL AS CHRONIC AND SEVERE ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL IMPLANT.

  Patient problems: Abdominal Pain; Hernia; Injury

  MAUDE report 9610925 ↗
• InjuryJan 21, 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 HERNIA RECURRENCE AS WELL AS CHRONIC AND SEVERE ABDOMINAL PAIN.

  Patient problems: Abdominal Pain; Hernia; Injury

  MAUDE report 9610912 ↗
• InjurySep 11, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 CHRONIC WOUND, SINUS AND WOUND INFECTION, INFECTED ABDOMEN AND WOUND WITH WOUND SINUS, CHRONIC DRAINING SINUS, CHRONIC NON-HEALING WOUND, INFECTED MESH, UNINCORPORATED MESH, AND FISTULA TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF CHRONIC WOUND, APPLICATION OF WOUND VAC, REMOVAL OF SEVERAL PIECES OF MESH MATERIAL, DEBRIDEMENT WITH REMOVAL OF MESH, AND EXCISION OF RETAINED MESH WITH NONHEALING WOUND EXPLORATION AND DEBRIDEMENT. THE DEVICE HAD BEEN USED WITH CONCOMITANT DEVICES WL GORE MYCROMESH PLUS 15 X 19 (X2), LOT #'S 13374847 AND 15148973.

  Patient problems: Discharge; Fistula; Impaired Healing; Injury; Unspecified Infection

  MAUDE report 8987447 ↗
• InjuryJun 18, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, DISCOMFORT, RIGHT CORD LIPOMA, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERIES AND RIGHT INGUINAL HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Injury; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 8709184 ↗