ProGrip PP3030GRecalls & reported problems
Sofradim Production · Self-Gripping Polypropylene Mesh Polypropylene with Polylactic Acid Grips · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521844308), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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 Problem1
- Patient Device Interaction Problem1
Patient problems
- Adhesion(s)1
- Constipation1
- Decreased Appetite1
- Distress1
- Electrolyte Imbalance1
- Hypoxia1
- Muscle Weakness/Atrophy1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJul 30, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, BOWEL OBSTRUCTION, PERFORATION, PAIN, LOSS OF APPETITE, CORE MUSCLE WEAKNESS, CONSTIPATION, RESPIRATORY FAILURE, HYPOXIA, ELECTROLYTE IMBALANCE, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, MESH REVISION, HOSPICE CARE. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
Patient problems: Adhesion(s); Constipation; Decreased Appetite; Distress; Electrolyte Imbalance; Hypoxia; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Perforation; Respiratory Failure; Unspecified Tissue Injury
MAUDE report 22667824 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.