ProGrip PP1509GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521177635), received between Jul 14, 2021 and Nov 15, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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, INFECTION, RECURRENCE, INFLAMMATION, NERVE DAMAGE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Fibrosis; Hernia; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20696300 ↗
• MalfunctionJan 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL (TAPP) GROIN HERNIA PROCEDURE, THE PRODUCT WAS OPENED, THE MESH WAS DISCONNECTED IN THE MIDDLE; IT HAD NOT YET BEEN APPLIED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587805 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ONE DAY POST-OPERATIVELY ON A RIGHT INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD SEVERE CYSTITIS. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT HOWEVER IT DID NOT GO AWAY. THE PATIENT WENT TO THE UROLOGIST AND THE BLADDER WAS OKAY. WHEN THE SURGEON PERFORMED CT SCAN IT WAS FOUND OUT THAT WHERE THE NETWORK IS, THAT THE SURFACE OF THE BLADDER IS ALWAYS INFLAMED. ALLERGIC REACTION TO THE NET. BASED ON THE RESULTS OF THE ALLERGY TEST THE PATIENT WAS NEGATIVE, THAT MEANS THE PATIENT HAD NO NEGATIVE REACTION RELATED TO THE DEVICE.

  Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164581 ↗