Parietex TECR1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521180291), received between Oct 12, 2017 and May 19, 2026 — classified as 64 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (27 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 65 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25220162 ↗
• InjuryMay 8, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25128521 ↗
• MalfunctionFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT, FOLLOWING AN INGUINAL HERNIA PROCEDURE, THE PATIENT FELT PAIN ALMOST DAILY. ON THE LEFT PART, THE PATIENT HAS HAD SENSITIVITY LOSS. FOLLOWING THE PAIN, THE PATIENT HAD ULTRASOUNDS, MRI SCANS, AND SAW RHEUMATOLOGISTS AND DOCTORS. THE PAIN HAS AFFECTED THE PATIENT¿S RELATIONSHIPS, WORK, AND DAILY LIFE.

  Patient problems: Numbness; Pain

  MAUDE report 24337801 ↗
• InjuryOct 28, 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 RECURRENCE, PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23407136 ↗
• InjuryJun 16, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, SCARRING AND SORENESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, INTERVENTION SURGERY AND MEDICATION.

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

  MAUDE report 22214219 ↗
• InjuryMay 27, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, HEMATOMA, SPERMATIC CORD INVOLVEMENT, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ORCHIECTOMY.

  Patient problems: Adhesion(s); Hematoma; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 22090933 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN 2012, THE PATIENT UNDERWENT A SECOND SURGERY FOR RECURRENCE OF AN INGUINAL HERNIA, AFTER A FIRST OPERATION POORLY PERFORMED. DURING THIS SECOND SURGERY, A MESH WAS IMPLANTED. FOLLOWING THIS INSTALLATION, THE HEALTH OF THE PATIENT GRADUALLY DETERIORATED. THE PATIENT EXPERIENCED SEVERE DIGESTIVE DISORDERS, PERSISTENT ABDOMINAL PAIN, FOOD INTOLERANCES, CHRONIC FATIGUE, COGNITIVE DISORDERS, AND MEMORY LOSS. IT SIGNIFICANTLY AFFECTED THE QUALITY LIFE OF THE PATIENT. IN (B)(6) 2017, A NEW RECURRENCE OF THE HERNIA REQUIRED A THIRD SURGERY WHICH IS A LEFT GROIN HERNIA CURE BY PREPERITONEAL LAPAROSCOPIC WITH PLACEMENT OF PROSTHESIS, WITH INSTALLATION OF ANOTHER TYPE OF MESH, BUT WITH DESPITE THIS NEW OPERATION, THE SYMPTOMS ALREADY PRESENT HAVE NOT DISAPPEARED, AND SOME WORSENED OVER TIME. THE PATIENT¿S SOCIAL LIFE WAS ALMOST NON-EXISTENT, LIMITED TO A PROFESSIONAL ACTIVITY MADE EXTREMELY DIFFICULT BY FREQUENT TRIPS TO THE TOILET, BETA-BLOCKER TREATMENT FOR RECURRENT MIGRAINES. THE DISORDERS APPEARED GRADUALLY BUT ARE NOW CHRONIC AND VERY DISABLING, WITHOUT IMPROVEMENT DESPITE A RIGOROUS LIFESTYLE AND SEVERAL MEDICAL CONSULTATIONS. ON THE CONTRARY, CERTAIN SYMP

  Patient problems: Abdominal Pain; Fatigue; Fecal Urgency; Headache; Hypersensitivity/Allergic reaction; Memory Loss/Impairment

  MAUDE report 22084960 ↗
• InjuryNov 1, 2024Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity 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 MESH SHRINKAGE, MESH EVENTRATION, MESH BALLED, RECURRENCE, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20588067 ↗
• InjuryNov 1, 2024Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity 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 MESH SHRINKAGE, MESH EVENTRATION, MESH BALLED, RECURRENCE, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20588022 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19732711 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19732670 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN, SPERMATIC CORD INVOLVEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Distress; Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19731643 ↗
• InjuryFeb 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND INCARCERATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18804225 ↗
• InjuryAug 14, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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, PAIN, AND CURLED UP MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17547254 ↗
• InjuryApr 25, 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 THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16811876 ↗
• 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 RECURRENCE, ADHESIONS, <(>&<)> PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, WOUND VAC, <(>&<)> MESH REMOVAL.

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

  MAUDE report 16016137 ↗
• InjuryAug 13, 2021Mechanics 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, INFLAMMATORY REACTION TO MESH, ABSCESS, DRAINING WOUND, FISTULOUS TRACT EXTENDING TO MESH, DEFECTIVE MESH, FAILURE OF MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING, AND GRANULOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC PLACEMENT, REMOVAL OF MESH, AND REVISION SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Emotional Changes; Fistula; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12318373 ↗
• InjuryJun 18, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DISFIGURATION OF PELVIC AREA, BACTEREMIA, DISLODGED MESH, MESH MIGRATION, ABDOMINAL WOUND SEROMA, FLUID COLLECTION, NON-HEALING WOUND, EXPOSED MESH, MESH NOT INCORPORATED, MESH FREE FLOATING, RECURRENCE, ABSCESS, DRAINAGE FROM WOUND, ABDOMINAL PAIN, FISTULOUS TRACTS, PAIN, SINUS TRACT, PURULENT DRAINAGE, SUTURE GRANULOMA, INFLAMMATION, NECROSIS, INFECTION, ADHESIONS, FIBROADIPOSE TISSUE, FIBROSIS, FOREIGN BODY GIANT CELL REACTION, ULCERATION, GRANULATION TISSUE, HIGH WBC COUNT, FEW WBC, SCAR, LEUKOCYTOSIS, STAPHYLOCOCCUS AUREUS, ACINETOBACTER BAUMANII, XANTHOGRANULOMATOUS TISSUE, PSEUDOMONAS AERUGINOSA, AND INFECTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF BLAKE AND PENROSE DRAINS, WOUND CARE, AT LEAST 3 WEEKS OF ANTIBIOTICS, MEDICATION, CT SCAN, WOUND VAC PLACED, INCISION/DRAINAGE OF ABDOMINAL WOUND SEROMA, ASPIRATION OF FLUID COLLECTION, REMOVAL OF MESH, RESECTION OF NON-HEALING WOUND, INCISION/DRAINAGE OF ABSCESS WITH SUTURE GRANULOMA, DEBRIDEMENT OF INFLAMED NECROTIC TISS

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Deformity/ Disfigurement; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Granuloma; Hernia; Impaired Healing; Inflammation; Necrosis; Pain; Purulent Discharge; Scar Tissue; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12025388 ↗
• InjuryMay 18, 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 A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, NERVE DAMAGE, INFECTION, FISTULA, OBSTRUCTION, CONSTIPATION, HERNIA RECURRENCE, MESH BULGED UP, ADHESIONS, CHRONIC ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HERNIA REPAIR WITH NEW MESH, EXPLORATORY LAPAROTOMY, LAPAROSCOPIC LYSIS OF ADHESIONS, PARTIAL MESH EXPLANT, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Constipation; Fistula; Hernia; Nerve Damage; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11844196 ↗
• InjuryApr 2, 2021Migration 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 DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS BY LAPAROSCOPIC SURGERY AND AN UMBILICAL HERNIA BY PRIMARY REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BULGE, RECURRENCE, MESH CONTRACTED/BALLED UP/WADDED UP, EMOTIONAL DISTRESS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Distress; Hernia; Unspecified Tissue Injury

  MAUDE report 11607648 ↗
• InjuryFeb 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, LOSS OF ENJOYMENT OF LIFE, LOSS OF FLEXIBILITY IN LEFT GROIN/PELVIS, AND LIMITED MOBILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY AND ROBOTIC LEFT INGUINAL MESH PLUG REMOVAL WITH SUTURE REMOVALS.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 11384958 ↗
• InjuryJan 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED INFECTION, INFECTED MESH, ABSCESS, SCARRING, FIBROUS CONNECTIVE TISSUE, RECURRENCE, DRAINING SINUS, PURULENT MATERIAL, SCAR TISSUE, INDURATION, PAIN, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, DEBRIDEMENT OF WOUND/ABSCESS CAVITY, AND HERNIA REPAIR.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Fluid Discharge; Hernia; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11222287 ↗
• InjuryNov 2, 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 THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH FAILURE, LACK OF INCORPORATION, MESH MIGRATION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

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

  MAUDE report 10770648 ↗
• InjuryOct 13, 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 ABSCESS, RECURRENCE, BACTERIAL INFECTION(GRAM+ COCCI), INFECTION, INFLAMMATION, ULCERATION, NECROSIS, FOREIGN BODY REACTION, PURULENT MATERIAL, INSPISSATED DEBRIS, SCARRING, PAIN, SEROMA, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION TO HOSPITAL, HERNIA REPAIR WITH NEW MESH, WASHOUT, DEBRIDEMENT OF ABDOMINAL WALL, REMOVAL OF MESH, AND WOUND VAC. CONCOMITANT DEVICES: UNKNOWN TITANIUM TACKS (8) RELEVANT TESTS/LABORATORY DATA: (B)(6) 2020: INTRAOPERATIVE WOUND CULTURES SHOWED GRAM + COCCI (B)(6) 2020: PATHOLOGY REPORT FROM SOFT TISSUE AND MESH SPECIMEN SHOWED MARKED ACUTE AND CHRONIC INFLAMMATION WITH ULCERATION, INFLAMED GRANULATION TISSUE FORMATION, FAT NECROSIS, FOREIGN BODY GIANT CELL REACTION TO CHOLESTEROL [SIC, MEANING UNCLEAR].

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Ascites; Bacterial Infection; Cellulitis; Chills; Erythema; Fever; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Injury; Necrosis; No Code Available; Nodule; Pain; Purulent Discharge; Scar Tissue; Scarring; Seroma; Stomach Ulceration; Swelling/ Edema; Tachycardia; Ulcer; Ulceration; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10673370 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE INFECTED MESH CAUSED MASSIVE INFECTION THAT BROKE TO THE SURFACE. THIS CONTINUED THROUGH 11 OPERATIONS UNTIL ALL THE MESH WAS OUT. A PORTABLE PUMP WAS USED TO HEAL QUICKER UNTIL IT REINFECTED EACH TIME. THE DRESSING WAS CHANGED THREE TIMES A WEEK.

  Patient problems: Unspecified Infection

  MAUDE report 10672963 ↗