Parietex TET1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10884521179974), received between Oct 12, 2017 and Mar 4, 2026 — classified as 2 deaths, 70 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (24 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24506631 ↗
• InjuryMar 31, 2025Adverse 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Ascites; Distress; Hematoma; Impaired Healing; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21731582 ↗
• InjuryMar 31, 2025Adverse 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Ascites; Distress; Hematoma; Impaired Healing; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21731574 ↗
• InjurySep 4, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20140243 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC BILATERAL DIRECT INGUINAL HERNIA REPAIR WITH TWO TENSION-FREE HERNIA PATCHES UNDER GENERAL ANESTHESIA, THE PATIENT SUFFERED FROM ABDOMINAL DISTENSION AND DISCOMFORT AFTER THE OPERATION. RE-EXAMINATION SHOWED OBVIOUS TENDERNESS AND REBOUND TENDERNESS IN THE SURGICAL AREA. THE REEXAMINATION OF ABDOMINAL CT SHOWED POSTOPERATIVE EDEMA AND EXUDATION. PATCH INFECTION WAS TO BE CONSIDERED.

  Patient problems: Discomfort; Swelling/ Edema; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 18067099 ↗
• InjuryJun 22, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, MEDICATION, MESH REMOVAL AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 17183307 ↗
• InjuryMay 23, 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, ADHESIONS, SMALL BOWEL OBSTRUCTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 16989582 ↗
• InjuryMar 3, 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 LAP INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SCARRING, ACUTE CHRONIC PAIN, INFECTION, HERNIA RECURRENCE AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 16479751 ↗
• InjuryDec 20, 2022Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, FISTULA, & PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, & MESH REMOVAL.

  Patient problems: Discomfort; Distress; Fistula; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16018012 ↗
• InjuryOct 14, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, IMPAIRMENT, PAIN, RECURRENCE, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15606563 ↗
• InjuryAug 25, 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 THE IMPLANT, THE PATIENT EXPERIENCED MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 15299034 ↗
• InjuryJul 21, 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 ADHESIONS, PAIN, NERVE DAMAGE, NERVE ENTRAPMENT, SPERMATIC CORD INVOLVEMENT, AND WADDED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Depression; Fibrosis; Foreign Body Reaction; Headache; Nerve Damage; Numbness; Pain; Scar Tissue; Sleep Dysfunction; Suicidal Ideation; Unspecified Tissue Injury

  MAUDE report 15075693 ↗
• InjuryJun 2, 2022Migration 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH EROSION AND MESH MIGRATION.

  Patient problems: Erosion; Hernia; Pain; Perforation; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14575569 ↗
• InjuryMay 20, 2022Migration 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 MESH MIGRATION AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Inflammation; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14459364 ↗
• InjuryAug 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION/ INFECTED MESH, PURULENT MATERIAL, GRANULATION TISSUE, ADHESIONS, AND SINUS TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND DEBRIDEMENT OF ABDOMINAL WALL OF SKIN/SUBCUTANEOUS TISSUE, MUSCLE AND INFECTED MESH.

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

  MAUDE report 12371475 ↗
• InjuryAug 13, 2021Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OMENTAL ADHESIONS, BUNCHED UP AREAS OF MESH, HERNIA RECURRENCE, PAIN, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 12321230 ↗
• InjuryJul 29, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, MESH FAILURE, DIASTASES, UMBILICAL BULGE, PAIN, HEMATOMA, OMENTUM PROTRUDING THROUGH DEFECT, LOWER HALF OF MESH HAD PULLED FREE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, MESH REMOVAL, CT SCAN, HERNIA REPAIR WITH MESH, PARTIAL MESH REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Emotional Changes; Failure of Implant; Hematoma; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 12245973 ↗
• InjuryJul 15, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 RECURRENT HERNIA DUE TO FAILURE OF THE MESH, MESH MIGRATION AND TEARING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Failure of Implant; Hernia; Unspecified Tissue Injury

  MAUDE report 12178820 ↗
• 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 A FLANK ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, CORD LIPOMA, SCARRING, HETEROGENOUS RIGHT TESTIS WITH LOW FLOW, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12134836 ↗
• InjuryJun 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, SCAR, ABDOMINAL PAIN, HERNIA RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, MESH REMOVAL, EXPLORATORY LAPAROTOMY, SCAR EXCISION AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12067695 ↗
• InjuryJun 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, SCAR, ABDOMINAL PAIN, HERNIA RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, MESH REMOVAL, EXPLORATORY LAPAROTOMY, SCAR EXCISION AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12067683 ↗
• InjuryApr 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, INFECTION, SCARRING, HERNIA RECURRENCE, HEMATOMA, WOUND WITH PERSISTENT DRAINAGE, OPEN WOUND, ADHESIONS, NECROTIC TISSUE, GRANULATION TISSUE, FOREIGN BODY INFECTION, UNINCORPORATED MESH, FREE FLOATING MESH, PURULENT MATERIAL, PANNUS, OPEN TUNNEL TRACTS, SINUS TRACT, PAIN, DIASTASIS, AND OOZING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND EXPLORATION, EXCISION OF MESH, CHOLECYSTECTOMY, DEBRIDEMENT OF WOUND, INCISION AND DRAINAGE OF WOUND, SCAR REVISION, PRIMARY REPAIR OF HERNIA, EVACUATION OF HEMATOMA, WOUND PACKED WITH ANTIBIOTIC CONTAINING GAUZE, GRANULATION TISSUE DEBRIDED, EXCISION OF SINUS TRACT, NECROTIC TISSUE REMOVED, PIECE OF LOWER ABDOMINAL SKIN REMOVED, SCAR REVISION, PAIN MEDICATION, WOUNDS IRRIGATED WITH ANTIBIOTIC SOLUTION, AND CAUTERIZED/COAGULATION OF OOZING.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Pannus; Fluid Discharge; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Necrosis; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11715833 ↗
• InjuryApr 2, 2021Mechanics 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INJURY, DAMAGE, ABDOMINAL PAIN, RECURRENCE, DEFECTIVE MESH, PAIN, MENTAL PAIN, EMOTIONAL DISTRESS, DISABILITY, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH PARIETEX MESH, AND MEDICATION.

  Patient problems: Abdominal Pain; Distress; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11611598 ↗
• InjuryMar 5, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RIGHT INGUINAL PAIN, RECURRENCE, HYDROCELE, SWELLING, ORCHIALGIA, EMOTIONAL DISTRESS, AND TESTICULAR PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NEURECTOMY OF RIGHT GENITOFEMORAL NERVE, HYDROCELECTOMY, AND REMOVAL OF TACKS. RELEVANT TESTS/LABORATORY DATA: 19 JAN 2011: PER OP NOTE, CT SCAN DEMONSTRATED SIGNIFICANT AMOUNT OF FAT WITHIN INGUINAL CANAL CONCERNING FOR EITHER RECURRENT INGUINAL HERNIA OR POSSIBLE RETAINED SPERMATIC CORD FAT. 21 MAR 2011: PER OP NOTE, US REVEALED HYDROCELE ON RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11422356 ↗
• InjuryFeb 12, 2021Migration 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 PAIN, MESH MIGRATION, RECURRENCE, INFECTION, ADHESIONS, AND LACK OF INCORPORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION OF MESH AND REPAIR OF HERNIA WITH NEW MESH.

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

  MAUDE report 11322135 ↗