Parietex TET2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521180352), received between Sep 21, 2017 and Jan 24, 2025 — classified as 2 deaths, 34 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 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 RECURRENCE, INFECTION, ADHESIONS, OPEN DRAINING WOUND, INFLAMMATION, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Discomfort; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21231080 ↗
• InjuryJul 22, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, AND PELVIC FLOOR DYSSYNERGIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 19790869 ↗
• InjuryNov 20, 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, PAIN, SEROMA, INCARCERATION, AND CHRONIC INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 18178647 ↗
• InjuryApr 26, 2023Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILED, ADHESIONS, PAIN, MESH SEPARATED, DEFECTIVE DEVICE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, UNABLE TO REMOVE MESH, HERNIA REPAIR, LYSIS OF ADHESIONS, AND PLACEMENT OF DRAIN.

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

  MAUDE report 16819812 ↗
• InjuryMar 7, 2023Migration 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, FISTULA, ADHESIONS, PAIN, MESH EROSION, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND WOUND VAC.

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

  MAUDE report 16499816 ↗
• InjurySep 2, 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 IMPLANT, THE PATIENT EXPERIENCED ADHESIONS TO BOWEL, ADHESIONS, HERNIA RECURRENCE, AND SEVERE AND CHRONIC PAIN/DISCOMFORT.

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

  MAUDE report 12416255 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATORY CHANGES, HISTIOCYTIC REACTION, ABNORMAL WBC AND HEMOGLOBIN, SEROSANGUINOUS DRAINAGE, MRSA, INCREASING ABDOMINAL DISTENTION, SINUS TRACT, SCAR TISSUE, FLUID COLLECTION, OPEN DRAINING WOUND, ADHESIONS, BENIGN EPIDERMAL INCLUSION CYST, INFLAMMATION, FISTULA, HERNIA RECURRENCE, INFECTION, ABSCESS, SWISS CHEESE DEFECT, AND DEVITALIZED TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, CT SCAN, HOSPITALIZATION, REVISION SURGERY, EXCISIONAL DEBRIDEMENT OF CHRONIC SKIN/SUBCUTANEOUS TISSUE SINUS TRACT AND ABSCESS, MESH REMOVAL, IV ANTIBIOTICS, ORAL ANTIBIOTICS, INDWELLING DRAINS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12414677 ↗
• InjuryAug 13, 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 INCISIONAL LEFT FLANK HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, INFECTION, PURULENT DRAINING SINUS TRACT, CONSTIPATION, INFLAMMATION, LOSS OF APPETITE, CHRONIC PAIN, SUFFERING, BLEEDING, FISTULAS, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, EXCISION OF SINUS, PURULENT DRAINAGE REMOVED, CT SCAN, WOUND VAC, AND MEDICATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Decreased Appetite; Fistula; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12319014 ↗
• InjuryJul 15, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEVICE DEFECT, RECURRENCE, ADHESIONS, SMALL BOWEL OBSTRUCTION AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12178836 ↗
• InjuryMay 7, 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 A ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED A REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cellulitis; Diarrhea; Hematoma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Nodule; Pain; Perforation; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 11791732 ↗
• InjuryMar 25, 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 AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH STITCHED TO OLD MESH.

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

  MAUDE report 11571475 ↗
• InjuryMar 27, 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 INFECTION, ADHESIONS, RECURRENCE, INFLAMMATION, NAUSEA, DIARRHEA, CHILLS, LOSS OF APPETITE, WEIGHT LOSS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Chills; Corneal Pannus; Decreased Appetite; Diarrhea; Discomfort; Erythema; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; Nausea; Necrosis; No Code Available; Nodule; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vasoconstriction; Weight Changes

  MAUDE report 9889181 ↗
• InjuryMar 27, 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 INFECTION, ADHESIONS, RECURRENCE, INFLAMMATION, NAUSEA, DIARRHEA, CHILLS, LOSS OF APPETITE, WEIGHT LOSS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Chills; Corneal Pannus; Decreased Appetite; Diarrhea; Erythema; Fluid Discharge; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; Nausea; Necrosis; No Code Available; Nodule; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vasoconstriction; Weight Changes

  MAUDE report 9889115 ↗
• InjuryMar 26, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED INFECTION, RECURRENCE, MESH CAME LOOSE, GROWN PEPTO STREPTOCOCCUS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Bacterial Infection; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Necrosis; No Code Available; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9883998 ↗
• InjuryJan 28, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, INFECTION, FAT NECROSIS, ORGAN LOSS, INFLAMMATION, DISLODGED MESH, STAPHYLOCOCCUS AUREUS, UNINCORPORATED MESH, HERNIA RECURRENCE, ABSCESS, GRANULATION TISSUE REACTION, PATCHY FIBROSIS, FOREIGN BODY REACTION, MRSA, INFECTION, DEAD TISSUE, SCAR TISSUE, PAIN, MESH MIGRATION AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, JP DRAINS, UMBILECTOMY AND MUSCLE DEBRIDEMENT, REVISION SURGERY, ABDOMINAL WALL RESECTION, REMOVAL OF MESH, ROTATIONAL ADVANCEMENT FLAP RECONSTRUCTION, PLACEMENT OF NEW MESH. RELEVANT TESTS/LABORATORY DATA (B)(6) 2018 SURGICAL PATHOLOGY- SPECIMEN: ABDOMINAL TISSUE WITH RETAINED MESH DIAGNOSIS : SOFT TISSUE WITH NECROSIS, ABSCESS, AND GRANULATION TISSUE REACTION. PATCHY FIBROSIS, FAT NECROSIS, AND FOREIGN BODY REACTION. NO MALIGNANCY PRESENT (B)(6) 2018 WOUND CULTURE- ORGANISM STAPHYLOCOCCUS AUREUS.

  Patient problems: Abscess; Bacterial Infection; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Injury; Necrosis; No Code Available; Pain; Scar Tissue; Seroma; Staphylococcus Aureus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9639119 ↗
• InjuryNov 13, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Injury; Seroma; Unspecified Infection

  MAUDE report 9314115 ↗
• InjurySep 24, 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 BILATERAL RECURRENT INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SCAR TISSUE, AND LARGE LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Injury; No Code Available; Scar Tissue

  MAUDE report 9108042 ↗
• DeathJun 14, 2019Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, ABSCESS, OPEN WOUND, RECURRENCE, INFLAMMATION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY WOUND VAC, AND VENTRAL INCISIONAL HERNIA REPAIR WITH MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Discharge; Erythema; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; High Blood Pressure/ Hypertension; Hypoxia; Impaired Healing; Inflammation; Injury; Necrosis; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Renal Failure; Respiratory Failure; Scar Tissue; Seroma; Staphylococcus Aureus; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 8701201 ↗
• InjuryJun 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Fluid Discharge; Hernia; Inflammation; Injury; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8687970 ↗
• InjuryMay 7, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, CHRONIC DRAINING SINUS TRACT, REMOVAL OF THE FOREIGN BODY WHICH WAS RESIDUAL MESH FROM A PREVIOUS PSEUDOSAC SEROMA, INFECTION, ABSCESS, MIGRATION AND OPEN ABDOMINAL WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE, WOUND VAC AND REVISION SURGERY.

  Patient problems: Abscess; Fluid Discharge; Impaired Healing; Injury; Seroma; Unspecified Infection

  MAUDE report 8589209 ↗
• InjuryApr 8, 2019Adverse 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 CHRONIC LEFT GROIN PAIN WITH RECURRENT LEFT INGUINAL HERNIA, USING LAP TECHNIQUE INCLUDING REMOVAL OF CORD LIPOMA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABDOMINAL PAIN, FLUID COLLECTION IN LEFT LOWER QUADRANT OF HERNIA REPAIR SITE, LEFT-LOWER QUADRANT INTRA-ABDOMINAL ABSCESS WITH INFECTION OF LAPAROSCOPIC MESH, DIVERTICULITIS/INFLAMMATION OF THE SIGMOID COLON WITH NO OBVIOUS PERFORATION, AND PURULENT MATERIAL BETWEEN THE MESH AND THE COLON. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAP EXAM WITH ASPIRATION OF FLUID FROM LEFT LOWER QUADRANT FOR CULTURE, CONVERSION OF OPEN EXPLORATORY LAPAROTOMY WITH REMOVAL OF LEFT LOWER QUADRANT MESH INCLUDING RECENT AND OLDER MESH, EXPLORATION OF SIGMOID COLON AND RESECTION OF THE SIGMOID COLON WITH LOW ANTERIOR COLON RESECTION, AND LEFT SUBCLAVIAN LINE PLACEMENT.

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

  MAUDE report 8492601 ↗
• InjuryApr 5, 2019Migration 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 RECURRENT LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFECTION, EXTENSIVE ADHESIONS, ABDOMINAL PAIN, FLUID COLLECTION IN LEFT LOWER QUADRANT AT SITE OF HERNIA REPAIR, INTRA-ABDOMINAL ABSCESS WITH INFECTION, DIVERTICULITIS/INFLAMMATION ON THE SIGMOID COLON, PURULENT MATERIAL BETWEEN THE MESH AND COLON, SIGMOID COLON WITH SIGNIFICANT INFLAMMATORY CHANGES, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF RECURRENT LEFT INGUINAL HERNIA USING LAPAROSCOPIC TECHNIQUE INCLUDING REMOVAL OF CORD LIPOMA, LAPAROSCOPIC EXAM WITH ASPIRATION OF FLUID FROM LEFT LOWER QUADRANT FOR CULTURE, CONVERSION TO OPEN EXPLORATORY LAPAROTOMY WITH REMOVAL OF LEFT LOWER QUADRANT MESH INCLUDING RECENTLY PLACED MESH AND ALSO REMOVAL OF PREVIOUSLY PLACED MESH PRODUCT, EXPLORATION OF THE SIGMOID COLON AND RESECTION OF THE SIGMOID COLON WITH LOW ANTERIOR COLON RESECTION, AND LEFT SUBCLAVIAN CENTRAL LINE PLACEMENT. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2018: CULTURES FROM LEFT LOWER QUADRANT FLUID COLLECTI

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Hernia; Inflammation; Injury; Necrosis; No Code Available; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8487225 ↗
• InjuryMar 29, 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 RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, INGROWTH OF BOWEL INTO MESH AND SEROSAL INJURIES TO THE BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED RECURRENT INCISIONAL HERNIA REPAIR WITH MESH.

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

  MAUDE report 8464633 ↗
• InjuryMar 26, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 8453324 ↗
• InjuryJan 7, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SURGICAL REVISION, ITCHING, PERSISTENT ABDOMINAL DISCOMFORT, INFLAMMATION, INFECTION, SEVERE PAIN AND MESH THAT WAS NOT WELL INCORPORATED. THE PATIENT HAS ONGOING MEDICAL ISSUES INCLUDING THE NEED FOR FUTURE MEDICAL TREATMENT, INCLUDING ADDITIONAL SURGICAL INTERVENTION. ALL MESH AND SUTURES HOLDING THE MESH WERE REMOVED ON (B)(6) 2015.

  Patient problems: Constipation; Discomfort; Inflammation; Injury; Itching Sensation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8223946 ↗