Parietene PPM1510X3Recalls & reported problems
Sofradim Production · Macroporous Mesh, Monofilament Polypropylene · Class 2 · Implant
Quick summary
This Sofradim Parietene surgical mesh is a polypropylene implant used to repair hernias. The 32 reports describe pain, inflammation, adhesions and the hernia coming back, with some patients needing revision surgery; 32 injuries and no deaths were reported. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521213821), received between May 11, 2020 and May 27, 2026 — classified as 32 injuries.
The most frequently reported specific device problem is “Mechanics Altered” (11 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 Problem32
- Mechanics Altered11
- Migration or Expulsion of Device7
- Patient Device Interaction Problem4
- Insufficient Device Problem Information2
- Material Deformation1
- Material Integrity Problem1
Patient problems
- Unspecified Tissue Injury32
- Hernia27
- Pain26
- Adhesion(s)16
- Inflammation13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Emotional Changes10
- Discomfort9
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25296412 ↗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 25221381 ↗InjuryMar 23, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24664925 ↗InjurySep 19, 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 EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Distress; Hernia; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 23099764 ↗InjuryAug 5, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, INCARCERATION, BOWEL PROBLEMS, AND DIARRHEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.
Patient problems: Adhesion(s); Diarrhea; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury
MAUDE report 22719533 ↗InjuryMar 31, 2025Migration 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 EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 21731781 ↗InjuryApr 16, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATION.
Patient problems: Hernia; Inflammation; Unspecified Tissue Injury
MAUDE report 19122129 ↗InjuryFeb 20, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, ALLERGIC REACTION, ADHESIONS, SEROMA, INFECTION, RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.
Patient problems: Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 18744525 ↗InjuryJan 11, 2024Adverse 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 A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ALLERGIC REACTION, SEROMA, PERFORATION, BOWEL ISSUES, CONTINUOUS DISCOMFORT. TREATMENT AND POTENTIALLY RELATED PROCEDURES INCLUDE MULTIPLE HERNIA REPAIRS, HERNIA REPAIR WITH NEW MESH.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Perforation; Seroma; Unspecified Tissue Injury
MAUDE report 18499079 ↗InjuryDec 21, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, ADHESIONS, RECURRENCE,PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, TAKE DOWN OF ADHESIONS.
Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 18374016 ↗InjuryNov 17, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.
Patient problems: Abdominal Pain; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 18161021 ↗InjuryJan 17, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NONHEALING WOUND, GRANULATION TISSUE, MESH NOT INCORPORATED, SCARRED, INDURATED TISSUE, FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, INFLAMMATION, ADHESIONS, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ILIOINGUINAL NERVE EXCISED, WOUND VAC, LEFT GROIN EXPLORATION, WOUND PAC WITH HYDROFERA BLUE AND COVERED WITH MEPILEX BORDER, PROLENE SUTURE REMOVED, TISSUE DEBRIDEMENT, REVISION SURGERY, MESH REVISION, REMOVAL OF MESH.
Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Impaired Healing; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 16185946 ↗InjuryNov 28, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, BLEEDING, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 15874828 ↗InjuryOct 7, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, IMPAIRMENT, NO LONGER HOLD SEXUAL RELATIONSHIP WITH WIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Hernia; Pain; Sexual Dysfunction; Unspecified Tissue Injury
MAUDE report 15563581 ↗InjuryApr 28, 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 DEFECTIVE MESH, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fibrosis; Hernia; Necrosis; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Tissue Injury
MAUDE report 14238863 ↗InjurySep 2, 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, MESH FAILURE, HERNIA RECURRENCE, PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REVISION SURGERY, AND COMPONENT SEPARATION.
Patient problems: Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 12418070 ↗InjuryAug 16, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE, MESH SEPARATED FROM WALL, SCARRING, SUTURE GRANULOMA, AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH SUTURES, HERNIA SAC ISOLATED AND EXCISED, AND REMOVAL OF MESH.
Patient problems: Distress; Granuloma; Hernia; Obstruction/Occlusion; Scar Tissue; Unspecified Tissue Injury
MAUDE report 12324486 ↗InjuryJul 15, 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 HERNIA RECURRANCE, ADHESIONS, SEVERE AND CHRONIC PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Discomfort; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 12174287 ↗InjuryJul 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH ON OLD NODULE WITH SCARRING, ABDOMINAL PAIN, PAIN, NAUSEA, VOMITING, AND BULGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PART OF SAC EXCISED, AND HERNIA REPAIR WITH MESH.
Patient problems: Abdominal Distention; Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Nausea; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting
MAUDE report 12111948 ↗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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS AND A SUPRAUMBILICAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, ADHESIONS, NAUSEA, VOMITING, PAIN, SMALL BOWEL OBSTRUCTION, FIBROFATTY TISSUE WITH MILD FIBROSIS, ABDOMINAL PAIN, COUGHING, BULGE, MESH PULLED AWAY, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH,BILATERAL COMPONENT SEPARATION, SAC EXCISED, AND MESH REMOVAL.
Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cough; Fibrosis; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting
MAUDE report 11861161 ↗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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN DURING BOWEL MOVEMENTS, AFFECTED SEX LIFE, PAIN DURING INTERCOURSE, RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND REMOVAL OF MESH.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Pain; Sexual Dysfunction; Unspecified Tissue Injury
MAUDE report 11829094 ↗InjuryMay 14, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, IMPAIRMENT, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, MESH FAILURE, HERNIA RECURRENCE, DISCOMFORT, AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION AND REVISION SURGERY.
Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hematoma; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 11828704 ↗InjuryMay 7, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Distress; Unspecified Tissue Injury
MAUDE report 11792705 ↗InjuryMay 6, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY WITH IMPLANT OF NEW MESH.
Patient problems: Failure of Implant; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 11785800 ↗InjuryApr 26, 2021Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ADHESIONS, MESH MIGRATION WITH BUNCHING, NON-HEALING WOUND, FAILURE OF MESH, MESH HAD DISTORTED, MESH PROTRUSION, FOREIGN BODY REACTION, AND CHRONIC INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.
Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Constipation; Discomfort; Electrolyte Imbalance; Emotional Changes; Erythema; Failure of Implant; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Necrosis; Nodule; Obstruction/Occlusion; Pain; Purulent Discharge; Sepsis; Seroma; Thrombocytopenia; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence
MAUDE report 11725514 ↗
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.