Parietex TECT1510ADPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521180161), received between Nov 8, 2017 and Jun 18, 2025 — classified as 47 injuries, 1 malfunction.

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. 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE MESH HAS A HOLE IN IT. A NEW PIECE OF MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22283110 ↗
• InjuryDec 22, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18380843 ↗
• InjuryJun 22, 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 RECURRENCE, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17185749 ↗
• InjuryNov 28, 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 RECURRENCE, ADHESIONS, MENTAL PAIN, PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Depression; Discomfort; Emotional Changes; Fatigue; Fibrosis; Hernia; Muscle Weakness/Atrophy; Numbness; Pain; Paresthesia; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15871875 ↗
• InjuryJul 14, 2022Migration 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 PAIN, MESH MIGRATION, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 15017450 ↗
• InjuryJan 21, 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 INFECTION, ABSCESS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Fistula; Inflammation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13324574 ↗
• InjuryAug 19, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, FAILURE OF IMPLANTS, PERMANENT PHYSICAL & EMOTIONAL HARM, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH MESH, MEDICATION.

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

  MAUDE report 12342849 ↗
• InjuryJul 29, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, MESH EROSION INTO BLADDER, INFLAMMATION, ABSCESS, FOREIGN BODY GRANULOMA, GRANULOMATOUS INFLAMMATION, UTI, PUS DRAINING OUT, PAIN, MESH MIGRATION, SCARIFICATION, INADEQUATE INGROWTH, AND BLADDER TUMOR. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, TRANSURETHRAL RESECTION OF BLADDER TUMOR, PARTIAL CYSTECTOMY, BLADDER WALL & ABSCESS CAVITY RESECTED, BIOPSY, CYSTOURETHROSCOPY, AND REVISION SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Erosion; Foreign Body Reaction; Granuloma; Inflammation; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 12245916 ↗
• InjuryMar 5, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, SINUS TRACT, ABSCESS, PAIN, AND MESH FREE FLOATING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Erythema; Fluid Discharge; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Itching Sensation; Muscle Weakness/Atrophy; Necrosis; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11422072 ↗
• InjuryJan 6, 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 A VENTRAL HERNIA AND AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11124412 ↗
• InjuryOct 6, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, ADHESIONS, PAIN, AND YELLOW-GREEN STAINS ON MESH DUE TO ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

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

  MAUDE report 10639680 ↗
• InjuryJul 20, 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 RECURRENCE, ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCKS AND MESH REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Dysuria; Emotional Changes; Erythema; Fibrosis; Granuloma; Hernia; Incontinence; Inflammation; Injury; Nausea; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 10296743 ↗
• InjuryJul 9, 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 THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, HERNIA RECURRENCE, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10254447 ↗
• InjuryMay 14, 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, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED NEURECTOMY AND REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Hernia; High Blood Pressure/ Hypertension; Inflammation; Injury; Nausea; Nerve Damage; No Code Available; Nodule; Pain; Unspecified Tissue Injury; Vomiting; Weight Changes

  MAUDE report 10057315 ↗
• 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 RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Injury

  MAUDE report 9974638 ↗
• InjuryJan 24, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NERVE DAMAGE, URINARY TRACT INFECTION, LOW ABDOMINAL/BACK/GROIN PAIN, SEPSIS, GENITOFEMORAL NEURALGIA (NERVE PAIN), GENITOFEMORAL NERVE ENTRAPMENT SYNDROME, PLASTERED APPENDIX TO MESH AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LEFT GENITOFEMORAL NEURECTOMY, CYSTOSCOPY, ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCKS, LAPAROSCOPIC APPENDECTOMY, AND SIGNIFICANT LYSIS OF ADHESIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Failure of Implant; Inflammation; Injury; Nerve Damage; No Code Available; Numbness; Pain; Paresthesia; Perforation; Scar Tissue; Sepsis; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 9629403 ↗
• InjuryJan 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SWELLING, TENDERNESS, SCARRING, INFECTION, ILEUS, SEROMA, MESH MIGRATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY INCLUDING SIGMOID COLON RESECTION AND PARTIAL BOWEL REMOVAL.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Seroma; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9610755 ↗
• InjuryJan 20, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, ADHESIONS, FLUID COLLECTION, DISCHARGE, SCARRING, PURULENT MATERIAL, INFECTION, GRANULOMATOUS TISSUE, FISTULA, OBSTRUCTION, INFLAMMATION, MESH SITTING FREELY IN PREPERITONEAL SPACE, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, DIAGNOSTIC LAPAROSCOPY, INCISION/DRAINAGE/DEBRIDEMENT OF ABSCESS, ADHESION REMOVAL, WOUND PACKED, IRRIGATION, END COLOSTOMY, TAKE DOWN OF FISTULA, CYSTOSCOPY WITH LEFT URETERAL STENT PLACEMENT, AND SIGMOID COLECTOMY.

  Patient problems: Abscess; Adhesion(s); Ascites; Discharge; Failure of Implant; Fistula; Fluid Discharge; Granuloma; Inflammation; Injury; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9606518 ↗
• InjuryNov 25, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, INFLAMMATION, INFLAMED APPENDIX, APPENDICULAR ADHESIONS AS WELL AS SEVERE AND PERSISTING PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION, LYSIS OF ADHESIONS, MESH EXPLANT AND APPENDIX REMOVAL.

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

  MAUDE report 9368483 ↗
• InjuryOct 28, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, ONGOING PAIN, NERVE DAMAGE, PAIN, MESH MIGRATION, NERVE ENLARGEMENT WITH INFLAMMATION AND CORD LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION BY WAY OF GROIN EXTRAPOLATION.

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

  MAUDE report 9243454 ↗
• InjuryOct 3, 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 INGUINAL HERNIA IN A LAPAROSCOPIC REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, AND A GRANULOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF SUTURE GRANULOMA, AND PLACEMENT OF NEW PARIETEX AND BARD PERFIX MESHES.

  Patient problems: Adhesion(s); Granuloma; Hernia; Injury

  MAUDE report 9153485 ↗
• InjuryOct 2, 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 INGUINAL HERNIA IN A LAPAROSCOPIC REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFLAMMATORY STRANDING, AND A FATTY CORD LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND PLACEMENT OF NEW BARD MESH.

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

  MAUDE report 9147858 ↗
• InjurySep 11, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RIGHT INGUINAL HERNIA RECURRENCE, NERVE DAMAGE, AND RIGHT GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PLACEMENT OF NEW MESH AND RESECTION OF ILIOINGUINAL NERVE.

  Patient problems: Hernia; Injury; Nerve Damage; Pain

  MAUDE report 9000689 ↗
• InjurySep 11, 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 BILATERAL RECURRENT INCARCERATED INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESION, MIGRATION AND RECURRING HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. THE DEVICE HAD BEEN USED WITH STRAP25 SECURESTRAP, LOT# GG6795.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8987641 ↗
• InjuryAug 18, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, OBSTRUCTION, INFECTED MESH, ABSCESS, DRAINING SINUS TRACT, INFECTION, LARGE PUS POCKET, AND THE RIGHT MESH WASN'T ADHERED AT ALL AND WAS RESTING WITHIN A LARGE ABSCESS CAVITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, EXPLORATORY LAPAROTOMY, EXCISION OF INFECTED MESH, AND DRAIN PLACEMENTS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Fluid Discharge; Hypersensitivity/Allergic reaction; Inflammation; Injury; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8904518 ↗