Parietex PCO4VP (UDI 10884521165700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10884521165700), received between Dec 14, 2017 and Jun 17, 2025 — classified as 98 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (45 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 99 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 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 HERNIA, PAIN, INFECTION, INFLAMMATION, ALLERGIC REACTION, BOWEL OBSTRUCTION, BLEEDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, AND UMBILECTOMY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22238221 ↗
• InjuryJun 28, 2024Mechanics 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 SUPRAUMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, POSTERIOR RECTUS SHEATH RELEASE.

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

  MAUDE report 19638415 ↗
• MalfunctionFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, AFTER THE OPEN HERNIA REPAIR PROCEDURE, THE PATIENT CLAIMED TO HAVE COMPLICATIONS DUE TO THE DYE CONTAINED IN THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 18813255 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN VENTRAL HERNIA REPAIR, THE PATIENT DEVELOPED A WOUND INFECTION AND THE MESH NEEDED TO BE EXPLANTED.

  Patient problems: Laceration(s); Unspecified Infection

  MAUDE report 17821424 ↗
• InjuryAug 4, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, RECURRENCE, ADHESIONS, EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17463987 ↗
• InjuryMay 30, 2023Mechanics 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, INFECTION, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING, GRANULATION TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17020238 ↗
• InjuryMay 25, 2023Migration 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 THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17007049 ↗
• 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 AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Hernia; Inflammation; Nausea; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 16989409 ↗
• InjuryJul 14, 2022Material 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, ABDOMINAL WALL ABSCESS, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, DEFECTIVE MESH, MESH FAILURE, MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND MESH REVISION.

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

  MAUDE report 15016638 ↗
• InjuryJun 23, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, SCARRING, NERVE DAMAGE, DEFECTIVE DEVICE, MESH FAILURE, MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL.

  Patient problems: Emotional Changes; Hematoma; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14790993 ↗
• InjuryMay 4, 2022Migration 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL ANGUISH, EMOTIONAL DISTRESS, ADHESIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED APPENDECTOMY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH MESH.

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

  MAUDE report 14283232 ↗
• InjuryMar 24, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN, INJURY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Distention; Emotional Changes; Hematoma; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 13872957 ↗
• InjuryMar 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 PAIN, INFLAMMATION, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13840741 ↗
• InjuryOct 26, 2021Migration 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ABDOMINAL PAIN, MENTAL/PHYSICAL PAIN, SUFFERING, I NFLAMMATION, ADHESIONS, MESH MIGRATION, DEVICE DEFECTIVE, SCARRING, PERMANENT IMPAIRMENT AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12701450 ↗
• InjuryOct 24, 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 THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nodule; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12686962 ↗
• InjuryOct 24, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC SEVERE PAIN, BODY ACHES, INFLAMMATION, CONSTIPATION, EXTREME WEIGHT GAIN, HOT FLASHES, MALAISE, POLYARTHRALGIAS, FATIGUE, WEAKNESS, LOSS OF STAMINA, DRY EYES, ANXIETY, INFECTED MESH, WRINKLED MESH, POLYARTHRALGIAS, ADHESIONS, FAILURE OF MESH, SCARRING, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL AND REVISION SURGERIES.

  Patient problems: Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Dry Eye(s); Emotional Changes; Fatigue; Hot Flashes/Flushes; Inflammation; Malaise; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 12686956 ↗
• InjuryJul 23, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DAMAGES, INJURIES, FAILURE OF MESH, PAIN, SUFFERING, EMOTIONAL DISTRESS, DIMINISHED QUALITY OF LIFE, ABDOMINAL PAIN, INFECTION, ADHESIONS, BOWEL OBSTRUCTION, DEFECTIVE DESIGN, DISABILITY, MENTAL ANGUISH, LOSS IN CAPACITY TO ENJOY LIFE, SCAR TISSUE, RECURRENCE, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATIONS, PROLONGED ANTIBIOTIC THERAPY, SURGERIES, WOUND CARE, NARCOTICS, PARTIAL REMOVAL OF MESH, DEBRIDEMENT OF FATTY TISSUE MUSCLE AND FASCIA, AND IRRIGATION.

  Patient problems: Abdominal Pain; Adhesion(s); Distress; Emotional Changes; Failure of Implant; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12217522 ↗
• InjuryJul 2, 2021Adverse 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. THE REPORTER STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

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

  MAUDE report 12112233 ↗
• InjuryMay 24, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, AND MESH REMOVAL.

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

  MAUDE report 11870325 ↗
• InjuryMay 20, 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. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, BULGING, INFLAMMATION, MESH MIGRATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND REMOVAL SURGERY.

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

  MAUDE report 11861109 ↗
• InjuryMay 14, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SEVERE PAIN, DISCOMFORT, OBSTRUCTION, & ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, & USE OF ABDOMINAL BINDER.

  Patient problems: Abdominal Pain; Discomfort; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 11828466 ↗
• InjuryMay 6, 2021Mechanics 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 AN UMBILICAL AND LEFT INGUINAL HERNIA . IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 11785731 ↗
• InjuryApr 26, 2021Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 UMBILICAL AND LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE GROIN PAIN, MESH FAILURE, MESHOMA, MESH CONTRACTION, MESH FOLDING, INFLAMMATION, MIGRATION, FAILURE TO INCORPORATE, ADHESIONS, AND NERVE ENTRAPMENT CAUSING CHRONIC LEFT GROIN AND TESTICULAR PAIN, SWELLING IN THE SCROTUM, LEFT INGUINODYNIA SECONDARY TO MESHOMA WITHIN THE DIRECT SPACE, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MESH REMOVAL SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Erosion; Failure of Implant; Foreign Body Reaction; Inflammation; Neuralgia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11729456 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUTURE GRANULOMAS, RECURRENCE, NAUSEA, AND FEELING OF PRESSURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, GRANULOMAS REMOVED, SKIN RESECTION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11578265 ↗
• InjuryMar 11, 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 PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MODIFICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11461976 ↗