ProGrip LPG1510X2Recalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh Polyester with Polylactic Acid Grips and Collagen Film · Class 2 · Implant
Quick summary
This Sofradim ProGrip self-fixating surgical mesh is implanted laparoscopically to repair hernias. Most of the 59 reports describe problems after implantation: the mesh shifting or moving, tissue sticking to it, the hernia coming back, and ongoing pain, with several patients needing revision surgery. There are 57 injuries and no deaths. No recalls name 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
- 60
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10884521513143), received between Jun 9, 2017 and Jul 30, 2026 — classified as 58 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (36 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 Problem58
- Mechanics Altered36
- Migration or Expulsion of Device16
- Insufficient Device Problem Information6
- Degraded3
- Patient Device Interaction Problem3
- Material Integrity Problem2
- Material Split, Cut or Torn1
Patient problems
- Pain56
- Unspecified Tissue Injury53
- Hernia44
- Emotional Changes39
- Scar Tissue32
- Adhesion(s)27
- Inflammation24
- Discomfort19
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Migration 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 inguinal hernia. It was reported that after implant, the patient experienced meshoma, pain, recurrence, inflammation and fold in mesh. Post-operative patient treatment included medication and resection of meshoma.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 50089630 ↗InjuryMay 18, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIC ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 25206547 ↗InjuryFeb 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24328335 ↗InjuryNov 17, 2025Adverse 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, ADHESIONS, 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, LYSIS OF ADHESIONS, ILIOINGUINAL NERVE BLOCK, REMOVAL OF MESH, DIAGNOSTIC LAPAROSCOPY.
Patient problems: Adhesion(s); Emotional Changes; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 23570906 ↗InjuryAug 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 22845781 ↗InjuryMay 28, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SWELLING.
Patient problems: Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 22097099 ↗InjuryMay 28, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, SWELLING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.
Patient problems: Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 22097098 ↗InjuryJan 7, 2025Migration 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 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 21093730 ↗InjuryAug 6, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Erectile Dysfunction; Hernia; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 19918991 ↗InjuryJul 15, 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 IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Discomfort; Emotional Changes; Hernia; Nausea; Pain; Unspecified Tissue Injury
MAUDE report 19746402 ↗InjuryJun 24, 2024Migration 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, MESHOMA, FOREIGN BODY REACTION, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 19595894 ↗InjuryJun 4, 2024Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.
Patient problems: Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 19460860 ↗InjuryMay 10, 2024Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH SHIFTED LATERALLY AND ANTERIORLY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 19294508 ↗InjuryMay 10, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS,SEROMA, OBSTRUCTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.
Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Sleep Dysfunction; Unspecified Tissue Injury
MAUDE report 19293583 ↗InjuryMar 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DECREASED SEX, HYDROCELE, CORD LIPOMA, CAN'T STAND FOR TOO LONG, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Nodule; Pain; Sexual Dysfunction; Unspecified Tissue Injury
MAUDE report 18992284 ↗InjuryFeb 26, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCAR TISSUE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 18779566 ↗InjuryFeb 5, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.
Patient problems: Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 18645661 ↗InjuryJul 13, 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, RECURRENCE, INFLAMMATION, ADHESIONS, BOWEL OBSTRUCTION, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 17317870 ↗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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, SCARRING, INFLAMMATION, NERVE DAMAGE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abdominal Pain; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 17019698 ↗InjuryMay 17, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SWELLING, DEFECTIVE MESH, RECURRENCE, PAIN, DISCOMFORT, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.
Patient problems: Deformity/ Disfigurement; Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 16947949 ↗InjuryMay 16, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, DEFECTIVE DEVICE, PAIN, MENTAL PAIN, SUFFERING, SCARRING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXPLORATORY LAPAROTOMY, EXPLANTATION OF MESH, ADHESIOLYSIS, PLACEMENT OF JP DRAIN, MEDICATION, AND HERNIA REPAIR WITH MESH.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16941199 ↗InjuryMay 9, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH MIGRATION, RECURRENCE, PAIN, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, SCARRING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MESH REVISION SURGERY.
Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16896154 ↗InjuryMay 1, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.
Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16845442 ↗InjuryMay 1, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.
Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 16845441 ↗InjuryMar 23, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, DIMINISHED QUALITY OF LIFE, DEVICE DEFECTIVE, DISCOMFORT, INFLAMMATION, HERNIA RECURRENCE, BURNING SENSATION, MENTAL ANGUISH, IMPAIRMENT OF DAILY ACTIVITIES, MENTAL PAIN, MESH FAILED, DISABILITY, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, REVISION SURGERY, ILIOINGUINAL NERVE LIGATED AND CUT, AND MEDICAL TREATMENT.
Patient problems: Burning Sensation; Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 16598885 ↗
Other Mesh, surgical, polymeric devices
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- 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.