Parietex TECT1510ADPRRecalls & reported problems
Sofradim Production · Hydrophilic Anatomical Mesh,Right Side, Polyester · Class 2 · Implant
Quick summary
This Sofradim Parietex surgical mesh is a polyester hernia repair implant placed in the abdominal or groin wall. Most of the 51 reports describe pain, the hernia coming back, and adhesions or scar tissue binding the mesh to nearby tissue, with some mentioning the mesh shifting position or deforming; several patients needed revision surgery to remove or replace it. No deaths were reported, and 51 injuries were. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884521180222), received between Nov 8, 2017 and Jul 7, 2025 — classified as 51 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (17 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem51
- Migration or Expulsion of Device17
- Mechanics Altered12
- Patient Device Interaction Problem10
- Insufficient Device Problem Information3
- Material Deformation3
- Degraded2
- Loss of or Failure to Bond1
Patient problems
- Pain39
- Unspecified Tissue Injury39
- Hernia38
- Injury36
- Adhesion(s)28
- Inflammation17
- No Code Available16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 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, ADHESIONS, PAIN.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 22424941 ↗InjuryJul 15, 2024Mechanics 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 PAIN, RECURRENCE, ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.
Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 19746857 ↗InjuryJan 5, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.
Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 18458846 ↗InjuryDec 21, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 18378333 ↗InjurySep 5, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Impaired Healing; Nodule; Pain; Unspecified Tissue Injury
MAUDE report 17687518 ↗InjuryAug 4, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 17464869 ↗InjuryJun 22, 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, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 17185733 ↗InjuryMay 29, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, MESH MIGRATION, SPERMATIC CORD INVOLVEMENT, NERVE DAMAGE, SCAR TISSUE, SPERMATIC CORD ENTRAPMENT, DENSE ADHERENCE OF PUBIC TUBERCLE, AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, LAPAROSCOPIC RIGHT RETROPERITONEAL TRIPLE NEURECTOMY, MESH ABDOMINAL REMOVAL, GENITAL NEURECTOMY, AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 17017424 ↗InjurySep 7, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, BOWEL COMPLICATIONS, RECURRENCE, MESH FAILURE, DEVICE DEFECTIVE, PAIN, SUFFERING, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, MENTAL PAIN, & LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, & HERNIA REPAIR WITH MESH.
Patient problems: Abdominal Pain; Discomfort; Distress; Emotional Changes; Hernia; Pain; Seroma; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 15375478 ↗InjurySep 7, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, BOWEL COMPLICATIONS, RECURRENCE, MESH FAILURE, DEVICE DEFECTIVE, PAIN, SUFFERING, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, MENTAL PAIN, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND HERNIA REPAIR WITH MESH.
Patient problems: Abdominal Pain; Discomfort; Distress; Emotional Changes; Hernia; Pain; Seroma; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 15375468 ↗InjuryAug 31, 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 ADHESIONS, VERY LARGE HARD MASS CONSISTENT WITH A SIGNIFICANTLY ALTERED HEMATOCELE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ORCHIECTOMY AND REVISION SURGERY.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nodule; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 15329197 ↗InjuryJan 21, 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 INFECTION, ABSCESS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abscess; Adhesion(s); Fistula; Inflammation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 13324577 ↗InjuryAug 19, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, FAILURE OF IMPLANTS, PERMANENT PHYSICAL EMOTIONAL HARM, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH MESH, MEDICATION.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 12342721 ↗InjuryMar 5, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction 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 RECURRENCE, INFECTION, SINUS TRACT, ABSCESS, PAIN, AND MESH FREE FLOATING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Erythema; Fluid Discharge; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Itching Sensation; Muscle Weakness/Atrophy; Necrosis; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 11421179 ↗InjuryFeb 5, 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 BILATERAL INGUINAL HERNIAS BY LAPAROSCOPIC SURGERY AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTED MESH, RECURRENCE, AND MESH CONTRACTION INTO A BALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.
Patient problems: Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 11286479 ↗InjuryOct 6, 2020Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, ADHESIONS, PAIN, AND YELLOW-GREEN STAINS ON MESH DUE TO ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.
Patient problems: Adhesion(s); Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 10638089 ↗InjurySep 23, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, WADDED UP MESH, MESH FOLDED UPON ITSELF, MESH MIGRATION, URINATION ISSUES, RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, HERNIA REPAIR WITH NEW MESH AND MEDICATION.
Patient problems: Adhesion(s); Discomfort; Hernia; Injury; Pain; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury
MAUDE report 10576986 ↗InjuryJul 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCKS AND MESH REMOVAL SURGERY.
Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Dysuria; Emotional Changes; Erythema; Fibrosis; Granuloma; Hernia; Incontinence; Inflammation; Injury; Nausea; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Retention
MAUDE report 10295259 ↗InjuryJul 9, 2020Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, HERNIA RECURRENCE, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Erosion; Hernia; Injury; Pain; Unspecified Tissue Injury
MAUDE report 10251258 ↗InjuryApr 17, 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Hernia; Injury
MAUDE report 9974646 ↗InjuryApr 8, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HARDENED MESH, MESH EROSION, NECROTIC BOWEL, PERFORATED BOWEL, INTERNAL HERNIA AND VOLVULUS (OBSTRUCTION). POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION AND PARTIAL REMOVAL OF PRIOR MESH.
Patient problems: Bowel Perforation; Erosion; Hernia; Injury; Obstruction/Occlusion
MAUDE report 9941661 ↗InjuryApr 6, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HARDENED MESH, MESH EROSION, PERFORATED BOWEL, RECURRENCE, VOLVULUS, ASCITES, ADHESIONS, GRANULOMA, ABDOMINAL PAIN, NAUSEA, VOMITING, TACHYCARDIA, ATRIAL FIBRILLATION, ISCHEMIC BOWEL, AND NECROTIC BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION, ANTRECTOMY OF 180 CM OF SMALL BOWEL WITH SIDE-TO-SIDE ANTIPERISTALTIC ANASTOMOSIS OF JEJUNUM TO ASCENDING COLON, INCIDENTAL APPENDECTOMY, TRANSFERRED TO THE ICU, AND PARTIAL REMOVAL OF MESH.
Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Atrial Fibrillation; Bowel Perforation; Erosion; Granuloma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Ischemia; Nausea; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Perforation; Tachycardia; Unspecified Tissue Injury; Vomiting; Weight Changes
MAUDE report 9929605 ↗InjuryApr 3, 2020Migration 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 AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abdominal Distention; Adhesion(s); Foreign Body Reaction; Hernia; Inflammation; Injury; Pain; Scar Tissue; Scarring; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 9920653 ↗InjuryFeb 28, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, HEMATOMA, RECURRENCE, NUMBNESS, SPOT OF SKIN HAS DIED, STINGING SENSATION INSIDE OF THING, SKIN BECOMES TENDER AFTER GETTING OUT OF SHOWER, RIGHT INGUINODYNIA AND CHRONIC GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, INJECTION THERAPY AND EXCISION OF THE RIGHT ILIOINGUINAL NERVE.
Patient problems: Discomfort; Hematoma; Hernia; Inflammation; Injury; Necrosis; Numbness; Pain; Unspecified Tissue Injury
MAUDE report 9770549 ↗InjuryJan 24, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NERVE DAMAGE, URINARY TRACT INFECTION, LOW ABDOMI NAL/BACK/GROIN PAIN, SEPSIS, GENITOFEMORAL NEURALGIA (NERVE PAIN), GENITOFEMORAL NERVE ENTRAPMENT SYNDROME, PLASTERED APPENDIX TO MESH, FAILURE OF MESH, AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LEFT GENITOFEMORAL NEURECTOMY, CYST OSCOPY, ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCKS, LAPAROSCOPIC APPENDECTOMY, AND SIGNIFICANT LYSIS OF ADHESIONS.
Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Failure of Implant; Inflammation; Injury; Nerve Damage; No Code Available; Numbness; Pain; Paresthesia; Perforation; Scar Tissue; Sepsis; Unspecified Tissue Injury; Urinary Tract Infection
MAUDE report 9629388 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.