Parietex TET1309DRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521180130), received between Jan 12, 2018 and Apr 14, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW MONTHS AFTER A RIGHT INGUINAL HERNIA SURGERY, THE PATIENT HAD A FISTULA IN THE PROSTHESIS THAT SUPPURATES AND KEPT COMING BACK FREQUENTLY WITH PAIN.

  Patient problems: Fistula; Pain; Purulent Discharge

  MAUDE report 24873762 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA, INTRAOPERATIVE FINDINGS REVEALED A VERY LARGE HERNIA CONTAINING A FIXED SIGMOID COLON, A LIPOMATOUS HERNIA, AND AN EXTERNAL OBLIQUE LIPOMA, WHICH WAS RESECTED DURING THE PROCEDURE. A LEFT INGUINAL HERNIA WAS DIAGNOSED AND TREATED WITH THE INTERPOSITION OF A POLYETHYLENE PLATE IN THE INTERMUSCULE, AND ANTIBIOTIC PROPHYLAXIS WAS ADMINISTERED INTRAOPERATIVELY. TWO MESH IMPLANTS WERE PLACED DURING THE SURGERY. POSTOPERATIVELY, THE PATIENT EXPERIENCED ONGOING DISCOMFORT AND PAIN AT THE IMPLANT SITES. AT THE END OF 2023 AND THE BEGINNING OF 2024, PAIN IN THE LOWER ABDOMEN BECAME MARKEDLY ACCENTUATED, AND THE PATIENT WAS HOSPITALIZED FOR AN AUTOIMMUNE DISEASE, WHICH WAS SUSPECTED TO HAVE BEEN TRIGGERED BY AN INFECTION.

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 24209812 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA, INTRAOPERATIVE FINDINGS REVEALED A VERY LARGE HERNIA CONTAINING A FIXED SIGMOID COLON, A LIPOMATOUS HERNIA, AND AN EXTERNAL OBLIQUE LIPOMA, WHICH WAS RESECTED DURING THE PROCEDURE. A LEFT INGUINAL HERNIA WAS DIAGNOSED AND TREATED WITH THE INTERPOSITION OF A POLYETHYLENE PLATE IN THE INTERMUSCULE, AND ANTIBIOTIC PROPHYLAXIS WAS ADMINISTERED INTRAOPERATIVELY. TWO MESH IMPLANTS WERE PLACED DURING THE SURGERY. POSTOPERATIVELY, THE PATIENT EXPERIENCED ONGOING DISCOMFORT AND PAIN AT THE IMPLANT SITES. AT THE END OF 2023 AND THE BEGINNING OF 2024, PAIN IN THE LOWER ABDOMEN BECAME MARKEDLY ACCENTUATED, AND THE PATIENT WAS HOSPITALIZED FOR AN AUTOIMMUNE DISEASE, WHICH WAS SUSPECTED TO HAVE BEEN TRIGGERED BY AN INFECTION.

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 24209805 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2022, THE PATIENT WITH A HISTORY OF UMBILICAL HERNIA FOR APPROXIMATELY 1 YEAR UNDERWENT AN EMERGENCY UMBILICAL HERNIA PROCEDURE, THE DEVICE/PROSTHESIS WAS THEN IMPLANTED IN PREFASCIA RETROMUSCULAR. FOLLOWING THE OPERATION, THE PATIENT EXPERIENCED ONSET OF VOMITING, CHRONIC DIARRHEA AND SEVERE ABDOMINAL PAIN. ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT OF ANOTHER HOSPITAL FOR ABDOMINAL PAIN. IT WAS NOTED THAT THE PATIENT HAS BEEN CONSULTING FOR RECURRENCE OF UMBILICAL HERNIA FOR A WEEK IN A CONTEXT OF DIARRHEA AND VOMITING ONCE A WEEK SINCE THE INITIAL PROCEDURE. IN THE EMERGENCY DEPARTMENT, THE PATIENT WAS STABLE AND DOES NOT SHOW SIGNS OF SEVERITY. THE ABDOMEN WAS FLEXIBLE AND DEPRESSIBLE, THE UMBILICAL HERNIA WAS REDUCIBLE AND NOT PAINFUL. NO SIGN OF SERIOUSNESS. A DOCTOR OF CARDIOVASCULAR (DCV) OPINION WAS TAKEN AND WAS NOTED THAT IN CONSULTATION WITH AN ABDOMINAL CT SCAN FOR REVISION SURGERY. BIOLOGY SHOWS NO IONIC DISORDER, NO ABNORMALITY OF RENAL FUNCTION, NO BIOLOGICAL INFLAMMATORY SYNDROME, NO ABNORMALITY OF THE COMPLETE BLOOD COUNT (CBC). THE PATIENT WAS THEN PRESCRIBED WITH AN ORAL MEDICATION FOR FIVE DAYS AND

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Diarrhea; Fatigue; Hernia; High Blood Pressure/ Hypertension; Ulcer; Unintended Radiation Exposure; Vomiting

  MAUDE report 22216252 ↗
• InjuryOct 24, 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, CHRONIC MESH INFECTION, CHRONIC DRAINING SINUS TRACT, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND NERVE TRANSECTED DUE TO MESH.

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

  MAUDE report 17999703 ↗
• InjuryAug 22, 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 RECURRENCE, ADHESIONS, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 15272089 ↗
• InjuryFeb 28, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN, NERVE DAMAGE, WADDED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13619933 ↗
• InjuryJun 18, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, HERNIA RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, MEDICATION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12026062 ↗
• InjuryMar 26, 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 INCISIONAL HERNIA BY LAPAROSCOPY AND A LEFT INGUINAL HERNIA BY OPEN REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, PLACEMENT OF DRAIN, REMOVAL OF GALLBLADDER, AND REPAIR OF HERNIA WITH MESH.

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

  MAUDE report 11577378 ↗
• InjuryMar 22, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND MESH INGROWN INTO FASCIA, MESH FAILURE, DISCOMFORT, EMOTIONAL HARM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.

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

  MAUDE report 11548176 ↗
• InjuryFeb 26, 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NERVE DAMAGE, PAIN, NERVE ENTRAPMENT, ADHESIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH SUTURES, AND NERVE RESECTIONS.

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

  MAUDE report 11385042 ↗
• InjuryDec 8, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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 RECURRENCE, MESH WAS LAX AND LOOSE, NUMBNESS, UNABLE TO PERFORM USUAL ACTIVITIES, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, VARIOUS MEDICATIONS, AND HERNIA REPAIR WITH PREVIOUS MESH SECURED. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2013: OP NOTE STATED ULTRASOUND CONFIRMED A RECURRENT LEFT INGUINAL HERNIA.

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

  MAUDE report 10971170 ↗
• InjuryOct 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, AND MESH SHIFTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Discomfort; Emotional Changes; Failure of Implant; Hernia; Injury; Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain; Unspecified Tissue Injury

  MAUDE report 10708620 ↗
• InjuryMay 12, 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 UMBILICAL HERNIA AND BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT SHORTLY AFTER IMPLANTATION, THE PATIENT EXPERIENCED RIGHT TESTICULAR PAIN, HERNIA PAIN, TEMPORARY DISABILITY, POSTOP NEUROPATHY, ILIO-INGUINAL NERVE ENTRAPMENT SYNDROME OR SCAR TISSUE AFFECTING THE RIGHT ILIOINGUINAL NERVE, SWELLING, AND SYMPTOMS CONSISTENT WITH ILIOINGUINAL NEURALGIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCK.

  Patient problems: Disability; Injury; Neuropathy; No Code Available; Pain; Scar Tissue; Swelling

  MAUDE report 10049165 ↗
• InjuryJan 20, 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 SEVERE PAIN, BURNING SENSATION IN GROIN, HERNIA RECURRENCE AND MESH PRODUCT FOUND BALLED UP POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9606463 ↗
• InjuryJan 2, 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 SEVERE PAIN, SUTURE GRANULOMAS, MESH REJECTION, HERNIA RECURRENCE, INFLAMMATORY REACTION AND CHRONIC WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED DEBRIDEMENT AND MESH REMOVAL.

  Patient problems: Foreign Body Reaction; Granuloma; Hernia; Impaired Healing; Inflammation; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9538197 ↗
• InjuryMar 28, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTED MESH, LACK OF INCORPORATION, SPERMATIC CORD INVOLVED AND GROSSLY PURULENT GELATINOUS MATERIAL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, GROIN EXCISION SOFT TISSUE MASS, INGUINAL HERNIA REMOVAL OF MESH, GROSSLY PURULENT GELATINOUS MATERIAL SUCTIONED OUT AND IRRIGATION OF WOUND.

  Patient problems: Abscess; Injury; No Code Available; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8461631 ↗
• InjuryDec 13, 2018Adverse 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 UMBILICAL HERNIA AND BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT SHORTLY AFTER IMPLANTATION, THE PATIENT EXPERIENCED RIGHT TESTICULAR PAIN, HERNIA PAIN, TEMPORARY DISABILITY, POSTOP NEUROPATHY, ILIO-INGUINAL NERVE ENTRAPMENT SYNDROME OR SCAR TISSUE AFFECTING THE RIGHT ILIOINGUINAL NERVE, SWELLING, AND SYMPTOMS CONSISTENT WITH ILIOINGUINAL NEURALGIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCK.

  Patient problems: Disability; Injury; Nerve Damage; Neuropathy; No Code Available; Pain; Scar Tissue; Swelling

  MAUDE report 8161053 ↗
• InjuryDec 9, 2018Adverse 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 RECURRENCE, DISCOMFORT, PAIN, AND SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 8145082 ↗
• InjuryJul 9, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE OUTCOME. TREATMENT AND POTENTIALLY RELATED PROCEDURES INCLUDE REMOVAL/REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Discomfort; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Injury; Ischemia; Nerve Damage; No Code Available; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7668873 ↗
• InjuryApr 24, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A ILIOINGUINAL NEUROPATHY AFTER INGUINAL RIGHT INGUINAL HERNIA REPAIR WITH MESH. SHE HAD REVISION SURGERY 8 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED INGUINAL PAIN, COMPLICATIONS LEADING TO RECURRENCE.

  Patient problems: Hernia; Injury; No Code Available; Pain

  MAUDE report 7454685 ↗
• InjuryApr 20, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS LEFT INGUINAL HERNIA. THE PROCEDURE PERFORMED WAS INGUINAL HERNIA REPAIR WITH PROSTHESIS OR GRAFT. THE PATIENT EXPERIENCED SURGICAL REVISION, NERVE ENTRAPMENT, AND PAIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Erectile Dysfunction; Erosion; Hernia; Inflammation; Injury; Nerve Damage; No Code Available; Numbness; Pain; Swelling/ Edema; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 7448010 ↗
• InjuryJan 12, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A LEFT INGUINAL HERNIORRHAPHY, MESH PLUG. HE HAD REVISION SURGERY 4 YEARS AND 7 MONTHS POST-OPERATIVE. THE PATIENT EXPERIENCED SURGICAL REVISION, PAIN, AND RECURRENCE..

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Injury; No Code Available; Pain; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 7186253 ↗