ProGrip LPG1510AK2Recalls & reported problems
Sofradim Production · Laparoscopic Self-Fixating Mesh, Left and Right Anatomical · Class 2 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521513181), received between Oct 31, 2019 and May 11, 2023 — classified as 9 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (3 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Mechanics Altered3
- Migration or Expulsion of Device2
- Patient Device Interaction Problem2
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- Pain9
- Unspecified Tissue Injury7
- Hernia6
- Adhesion(s)5
- Emotional Changes3
- Injury3
- Abdominal Pain2
- Burning Sensation2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2023Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, RECURRENCE, ADHESIONS, PERFORATION, NERVE DAMAGE, INFLAMMATION, INFECTION, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, ILIOINGUINAL/GENITOFEMORAL NEURECTOMIES, RETROPERITONEAL DISSECTION.
Patient problems: Abdominal Pain; Adhesion(s); Burning Sensation; Discomfort; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 16912565 ↗InjuryMay 11, 2023Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, RECURRENCE, ADHESIONS, PERFORATION, NERVE DAMAGE, INFLAMMATION, INFECTION, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, ILIOINGUINAL/GENITOFEMORAL NEURECTOMIES, RETROPERITONEAL DISSECTION.
Patient problems: Abdominal Pain; Adhesion(s); Burning Sensation; Discomfort; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 16912547 ↗InjurySep 9, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 12450698 ↗InjurySep 9, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 12450687 ↗MalfunctionAug 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A ROBOTIC INGUINAL HERNIA REPAIR, AFTER OPENING THE PACKAGING, THE MESH WAS RIPPED ALONG THE ANATOMICAL SEAM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305232 ↗InjuryMay 21, 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 11867107 ↗InjuryMay 19, 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION SURGERY.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 11851953 ↗InjurySep 24, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH FAILURE, MESH MIGRATION, ADHESIONS, MESH WRAPPED AROUND THE SPERMATIC CORD, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.
Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; Pain
MAUDE report 10582839 ↗InjurySep 21, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PHYSICAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, RECURRENCE, MESH FAILURE, MESH MIGRATION, ADHESIONS, MESH WRAPPED AROUND THE SPERMATIC CORD, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REVISION SURGERY.
Patient problems: Adhesion(s); Emotional Changes; Failure of Implant; Hernia; Injury; Pain; Unspecified Tissue Injury
MAUDE report 10564313 ↗InjuryOct 31, 2019Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RIGHT SIDED SPASTIC PAIN RADIATING TO TESTICLES, PROSTATE CANCER AND MESH TENTED BLADDER TO ANTERIOR ABDOMINAL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PROSTATECTOMY, CYSTOSCOPY, CYSTOTOMY REPAIR.
Patient problems: Adhesion(s); Cancer; Injury; Pain
MAUDE report 9259916 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.