ProGrip LPG1510ARRecalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh, Right Anatomical · Class 2 · Implant
Quick summary
This Sofradim ProGrip is a self-fixating surgical hernia mesh used in laparoscopic repair. Its 300 reports often describe pain, hernia recurrence and adhesions after implant, with some mesh changing shape, tearing or moving out of place. The reports include 3 deaths and 247 injuries, and several note that an attorney alleged a device deficiency. 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
- 300
- Deaths reported
- 3
- Injuries reported
- 248
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 10884521513167), received between Jun 16, 2017 and Aug 20, 2026 — classified as 3 deaths, 248 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (121 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 Problem250
- Mechanics Altered121
- Migration or Expulsion of Device72
- Material Split, Cut or Torn45
- Insufficient Device Problem Information25
- Patient Device Interaction Problem21
- Material Integrity Problem16
- Material Deformation13
Patient problems
- Pain210
- Unspecified Tissue Injury200
- Hernia195
- Adhesion(s)129
- Emotional Changes127
- Scar Tissue111
- Injury110
- Inflammation85
Recent adverse event reports
The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.
DeathAug 20, 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, death. Post-operative patient treatment included revision surgery. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.
Patient problems: Adhesion(s); Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 50356230 ↗InjuryJul 29, 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 inguinal hernia. It was reported that after the implant, the patient experienced testicular mass, testicular pain, hematuria, hernia recurrence, adhesions, pain, <(>&<)> bleeding. Post-operative patient treatment included hernia repair with mesh, diagnostic lap, lysis of adhesions, orchiectomy, <(>&<)> medication.
Patient problems: Adhesion(s); Hematuria; Hemorrhage/Blood Loss/Bleeding; Hernia; Nodule; Pain; Unspecified Tissue Injury
MAUDE report 50077118 ↗InjuryJul 28, 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 pain, recurrence, inflammation.
Patient problems: Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 50060149 ↗MalfunctionJun 24, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, DURING INSERTION OF THE MESH, THE MESH DISINTEGRATED AND TORE INTO TWO PIECES WITHIN THE PATIENT, WHICH WAS DETECTED AFTER INSERTION INTO THE PATIENT. IT WAS REPORTED THAT THE MESH LOOKED FINE PRIOR TO INSERTION, WAS NOT CUT PRIOR TO IMPLANTATION, AND WAS USED WITH A SELF-FIXATING METHOD. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO TIME WAS NEEDED TO REMOVE THE TORN MESH. THE MESH WAS RETRIEVED, AND A NEW MESH WAS OPENED AND INSERTED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611147 ↗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 EMOTIONAL DISTRESS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, LEFT HEMISCROTAL INGUINAL EXPLORATION WITH ORCHIECTOMY.
Patient problems: Distress; Pain; Unspecified Tissue Injury
MAUDE report 25204444 ↗InjuryMay 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 THE IMPLANT, THE PATIENT EXPERIENCED DISABILITY, EMOTIONAL DISTRESS, HERNIA RECURRENCE, PAIN, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, MESH REVISION, <(>&<)> HERNIA REPAIR WITH MESH.
Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25152993 ↗InjuryMay 8, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, UNABLE TO PERFORM PHYSICAL ACTIVITY, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.
Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25126973 ↗InjuryApr 8, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, EMOTIONAL CHANGES, DISCOMFORT, DISABILITY, LOSS OF ENJOYMENT OF LIFE.
Patient problems: Discomfort; Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24821450 ↗InjuryMar 20, 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24651445 ↗InjuryMar 20, 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 24651424 ↗InjuryFeb 3, 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, ADHESIONS, RECURRENCE, PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR AND MESH REVISION.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24249325 ↗InjuryJan 20, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.
Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24122123 ↗InjuryJan 20, 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, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.
Patient problems: Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24119118 ↗InjuryDec 4, 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 PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23719483 ↗InjuryDec 4, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23718875 ↗InjuryNov 26, 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, INCARCERATED HERNIA, ABDOMINAL DISTENTION, PAINFUL BOWEL MOVEMENTS, NAUSEA, ABDOMINAL PAIN, LIMITED ABILITY TO PERFORM PHYSICAL LABOR, UNABLE TO EXERCISE AND UNABLE TO LIFT. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, MEDICATION.
Patient problems: Abdominal Distention; Abdominal Pain; Hernia; Nausea; Pain; Unspecified Tissue Injury
MAUDE report 23659472 ↗InjuryNov 17, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, INCARCERATED HERNIA, MESH MIGRATION, CONSTIPATION, CRAMPS, INTESTINE STRANGULATION, INTESTINE TANGLED IN MESH AND TESTICULAR PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, HERNIA REPAIR WITH NEW MESH AND MEDICATION.
Patient problems: Adhesion(s); Constipation; Cramp(s) /Muscle Spasm(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 23575971 ↗InjuryNov 11, 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, INFLAMMATION, ADHESIONS AND GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.
Patient problems: Adhesion(s); Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 23528395 ↗InjuryOct 15, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Distress; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 23292523 ↗InjuryAug 22, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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, MESH MIGRATION, MESH SHRINKAGE, PAIN, ADHESIONS, RECURRENCE, NERVE DAMAGE, SEROMA, MESHOMA, URINARY TRACT INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NEURECTOMY, LYSIS OF ADHESION, AND MESH REMOVAL.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Nerve Damage; Pain; Seroma; Unspecified Tissue Injury; Urinary Tract Infection
MAUDE report 22873297 ↗InjuryAug 19, 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 THERAPEUTIC TREATMENT OF AN INGUINAL AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, DEFECTIVE MESH, FAILURE OF MESH, INFECTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, PERIPHERAL NEURECTOMY, WASHOUT OF ABSCESS, REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Abscess; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 22842342 ↗InjuryJun 16, 2025Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; Material Integrity 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 MESH CONTRACTION, MESH PROTRUSION, ALLERGIC REACTION, RECURRENCE, DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, BOWEL OBSTRUCTION, FISTULA, BLEEDING, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, 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, SMALL BOWEL RESECTION, MEDICATION,
Patient problems: Adhesion(s); Discomfort; Emotional Changes; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 22215326 ↗InjuryJun 6, 2025Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY.
Patient problems: Adhesion(s); Constipation; Depression; Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury
MAUDE report 22159695 ↗InjuryMay 19, 2025Mechanics 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 INGUINAL BILATERAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, RECURRENCE, PAIN, DISCOMFORT, AND EMOTIONAL HARM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 22048159 ↗MalfunctionMay 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A ROBOTIC INGUINAL HERNIA REPAIR, THE 10X15CM LP ANTMCL MESH RT WAS FOUND TO BE DAMAGED AS THE MESH TORE. THE ISSUE WAS DETECTED AFTER OPENING THE PACKAGING. A NEW PIECE OF MESH WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22038505 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.