Parietex TEC1309Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521180093), received between Sep 12, 2017 and Apr 15, 2026 — classified as 1 death, 57 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (16 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, SCARRING, INABILITY TO PERFORM HOME ACTIVITIES, DISCHARGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH AND MESH REVISION.

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

  MAUDE report 24887340 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 337 DAYS POSTOPERATIVELY, OF AN ABDOMINAL WALL HERNIA MESH REPAIR, THE PATIENT SUBSEQUENTLY DEVELOPED PAIN AND WAS DIAGNOSED WITH REJECTION MESH INFECTION, AND THE ABSCESS WAS FORMED DUE TO MESH INFECTION. AFTER 2 DAYS, AN ABSCESS DRAINAGE MESH REMOVAL WAS PERFORMED.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 21072602 ↗
• InjuryMay 28, 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 RIGHT INGUINAL HERNIA AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INTESTINAL BLOCKAGE, OPEN WOUND, HEMATOMA, BOWEL OBSTRUCTION, CHRONIC PAIN, ADHESIONS, MENTAL PAIN, SUFFERING, DEVICE DEFECTIVE, MESH FAILURE, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE/COMFORT/CONSORTIUM, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, REPAIR OF RECURRENT INGUINAL HERNIA, EXPLORATORY LAPAROTOMY.

  Patient problems: Adhesion(s); Emotional Changes; Hematoma; Hernia; Impaired Healing; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 19403137 ↗
• InjuryMay 17, 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINS PLACED.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 19346259 ↗
• InjuryJun 20, 2023Migration 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 17167447 ↗
• InjuryMay 31, 2023Adverse 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 INFECTION, FISTULA, ADHESIONS, PAIN, MESH EROSION INTO DIAPHRAGM, AND GASTRIC PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, JEJUNOSTOMY TUBE, CHEST TUBE AND JP DRAINS, AND HOME INFUSIONS THROUGH IV ANTIBIOTIC AND PICC LINES.

  Patient problems: Adhesion(s); Erosion; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17035362 ↗
• InjuryApr 22, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Fluid Discharge; Hernia; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14188430 ↗
• InjuryMar 17, 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 IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Hernia; Nodule; Pain; Unspecified Tissue Injury

  MAUDE report 13791592 ↗
• InjuryDec 20, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, FISTULA, CHRONIC DRAINING SINUS TRACT, ADHESIONS, PAIN, WOUND DEHISCENCE, SEROMA, SCARRING, ABDOMINAL PAIN, BLOATING, CHILLS, FEVER, SWELLING, PAIN FROM BENDING OVER OR WALKING LONG DISTANCES. POST-OPERATIVE PATIENT TREATMENT REVISION SURGERY, INCISION/DRAINAGE PROCEDURES, EXPLORATORY LAPAROTOMY, REMOVAL OF MESH, RESECTION OF DRAINING SINUS, REPAIR OF SEROSAL TEAR, MEDICATION, HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chills; Diaphoresis; Discomfort; Erythema; Fever; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Nodule; Pain; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13042579 ↗
• InjuryJul 15, 2021Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Distress; Fibrosis; Foreign Body Reaction; Headache; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Seroma; Sleep Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12174145 ↗
• InjuryApr 30, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, NUMBNESS, NERVE DAMAGE, SCAR TISSUE, MESH MIGRATION, INFECTION, INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH, FIBROSIS, ADIPOSE TISSUE, BULGE, BURNING SENSATION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, LEFT GROIN EXPLORATION, A REVISION SURGERY, REMOVAL OF MESH, ULTRASOUND, AND ILIOINGUINAL NEURECTOMY.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Nerve Damage; Numbness; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11753181 ↗
• InjuryMar 26, 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, AN UMBILICAL HERNIA, AND BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, FIBROCOLLAGENOUS SCAR TISSUE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, BILATERAL TRANSVERSUS ABDOMINIS RELEASES, AND HERNIA REPAIR WITH MESH. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2019: PATHOLOGY REPORT FROM PROSTHETIC MESH REMOVAL SPECIMEN SHOWED LIMITED ASSOCIATED FIBROCOLLAGENOUS SCAR TISSUE (B)(6) 2020: OP NOTE STATED ABDOMINAL CT SCAN SHOWED HERNIA IN THE SUPRAUMBILICAL REGION CONTAINING SMALL BOWEL.

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

  MAUDE report 11576068 ↗
• InjuryMar 25, 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, AN UMBILICAL HERNIA, AND BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, FIBROCOLLAGENOUS SCAR TISSUE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, BILATERAL TRANSVERSUS ABDOMINIS RELEASES, AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 11569329 ↗
• InjuryFeb 12, 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 AN UMBILICAL HERNIA AND AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, ABDOMINAL PAIN, RECURRENCE, INJURIES AND DAMAGES, PAIN AND SUFFERING, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, GENERAL DISTRESS, MENTAL PAIN, DISABILITY, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11322240 ↗
• InjuryJan 5, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC INFECTION, UNINCORPORATED MESH, AND REHERNIATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RIGHT INGUINAL HERNIA REPAIR, AND REMOVAL OF MESH/TACKS.

  Patient problems: Abnormal Vaginal Discharge; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11116593 ↗
• InjuryDec 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, FISTULA, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BELLY BUTTON REMOVAL, COLECTOMY, MESH REMOVAL, MEDICATION, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Fistula; Fluid Discharge; Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 11057460 ↗
• InjuryDec 8, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH WAS LAX AND LOOSE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH PREVIOUS MESH SECURED.

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

  MAUDE report 10972194 ↗
• InjurySep 22, 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH FAILURE, ADHESIONS, PAIN AND COMPLETE DEHISCENCE OF PRIOR REPAIR. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Failure of Implant; Hernia; Injury; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10568944 ↗
• InjurySep 22, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 RIGHT/LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, THICKENED SCAR TISSUE, FAILED MESH, EMOTIONAL DISTRESS, AND PURULENT MATERIAL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Distress; Failure of Implant; Injury; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10568938 ↗
• InjuryAug 14, 2020Adverse 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 LAPAROSCOPIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Inflammation; Injury; Nodule; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10410506 ↗
• InjuryJul 9, 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 THE IMPLANT, THE PATIENT EXPERIENCED OMENTUM HERNIATING OVER THE EDGE OF THE MESH, RECURRENCE, LAYER OF RECTUS SHEATH WAS BREACHED, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED COMPLEX ABDOMINAL WALL RECONSTRUCTION WITH MESH, COMPONENT SEPARATION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND REMOVAL SURGERY.

  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 10253480 ↗
• InjuryMay 28, 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 IN GROIN AREA, MESH MIGRATION, AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NEUROLYSIS, PATCH SECURED WITH SUTURES, AND REMOVAL SURGERY.

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

  MAUDE report 10098367 ↗
• InjuryMay 15, 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 PAIN, INFECTION, ABSCESS AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Injury; Pain; Seroma; Unspecified Infection

  MAUDE report 10061099 ↗
• InjuryApr 3, 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 ONLAY IMPLANT, THE PATIENT EXPERIENCED TENDER MASS, SCARRING, FOREIGN BODY, MIGRATED AND BALLED UP MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, EXCISION OF FOREIGN BODY, AND EXCISION OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body In Patient; Hernia; Injury; No Code Available; Nodule; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 9920669 ↗
• 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, HERNIA REPAIR WITH NEW MESH, BILATERAL RECTUS MUSCLE MYOFASCIAL RELEASES, MULTIPLE REVISION SURGERIES.

  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 9770478 ↗