ProGrip PP1208DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521177666), received between Aug 5, 2021 and Apr 21, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER THE PATIENT UNDERWENT A CURE OF A BILATERAL INGUINAL HERNIA USING THE MODIFIED TENSION-FREE LICHTENSTEIN TECHNIQUE WITH MESH IMPLANTATION ON (B)(6) 2025. THE PATIENT HAD AN ABDOMINAL COMPUTED TOMOGRAPHY SCAN WITHOUT INJECTION ON (B)(6) 2025. THERE WAS A SLIGHT SUBCUTANEOUS INFILTRATION REGARDING THE PERIORAL SITE WITHOUT AN ORGANIZED COLLECTION. ABSENCE OF UNMASKED HERNIA DURING PUSHING MANEUVERS. THE PATIENT HAD A CONSULTATION FOLLOWING AN ABDOMINAL COMPUTED TOMOGRAPHY SCAN WITHOUT INJECTION FOR A PELVIC PAIN ASSESSMENT, WITH RADIATION IN THE PENIS ESSENTIALLY NOCTURNAL AND ASSOCIATED WITH FREQUENT URINATION. THE CT SCAN DID NOT FIND ANYTHING. THE PHYSICAL ADVISED THE PATIENT TO GET IN TOUCH WITH A UROLOGIST. ON (B)(6) 2026, THE PATIENT HAD ANOTHER CONSULTATION DUE TO THE PROBLEM OF A PAINFUL, PERSISTENT, AND DISABLING SYMPTOMATOLOGY. EXAMINATION OF THE EXTERNAL GENITALIA REVEALED NO ABNORMALITIES, AND THE WALL HEALING WAS SATISFACTORY. THE CLINICAL PROSTATE EXAMINATION WAS REASSURING, AS WAS THE URINE DIPSTICK TEST AND THE ULTRASOUND CHECK OF BLADDER EMPTYING. IN THE EVENT OF POST-OPERATIVE ILIOINGUINAL NEURALGIA. A MAGNETIC RESONANCE IMAGING (MRI) WITH

  Patient problems: Pain; Swelling/ Edema; Unintended Radiation Exposure; Unspecified Kidney or Urinary Problem

  MAUDE report 24935887 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, BURNING, NUMBNESS, DISABILITY, INFLAMMATORY PAIN, FISTULA, ABDOMINAL PAIN, UNABLE TO WORK OR WALK, DIFFICULTY SLEEPING, SEVERE STIFFNESS, ANXIETY, DEPRESSION, INSOMNIA, INABILITY TO DRIVE, SUFFERING, FRUSTRATION, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, HUMILIATION, MESH FAILED, DEVICE DEFECTIVE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PAIN MEDICATION, TWO NERVE BLOCKS, IMAGING TESTING, MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Depression; Discomfort; Distress; Emotional Changes; Fistula; Inflammation; Numbness; Pain; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 23407711 ↗
• DeathApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT ON (B)(6) 2024 AN OPEN BILATERAL INGUINAL HERNIA CURE WAS PERFORMED USING THE LICHTENSTEIN TECHNIQUE WITH THE PLACEMENT OF TWO RETRO-APONEUROTIC PROSTHESES. THE PROCEDURE INVOLVED A DORSOL DECUBITUS POSITION UNDER GENERAL ANESTHESIA, INCISION IN THE RIGHT LOWER ABDOMINAL FOLD, OPENING OF THE EXTERNAL OBLIQUE FASCIA, DISSECTION OF A LARGE EXTERNAL OBLIQUE HERNIA, SPERM CORD RELEASE, DETACHMENT OF APONEUROTIC MARGINS, AND THE SPREAD OF A MESH PROSTHESIS ATTACHED TO THE PUBIS, CRURAL ARCH, AND CONJOINED TENDON BY SEPARATE POINTS OF A SUTURE. THE WOUND WAS CLOSED WITH APONEUROTIC CLOSURE, CLOSURE OF THE FASCIA CRIBRIFORMIS, NAROPENINE WALL INFILTRATION, AND NON-ABSORBABLE THREADS ON THE SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED SEVERE PAIN, INTERNAL BURNS ON THE RIGHT AND LEFT, NEEDLE STROKE SENSATION, AND UNPLEASANT DISCOMFORT IN THE TESTICLES WITH PAIN. THE PATIENT ALSO REPORTED FEELING AS IF HAVING BRUISES AND AN IMPRESSION OF HAVING CORRUGATED CARDBOARD INSIDE. THESE SYMPTOMS WERE EXACERBATED WHEN STANDING AND SITTING, LEADING TO WAKING UP AT NIGHT DUE TO NEEDLE STROKE AND BURNS, DIFFICULTY GOING BACK TO SLEEP, AND SOMETIMES SLEEPLESS NIGHTS. THE PAT

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Depression; Discomfort; Pain

  MAUDE report 21807766 ↗
• MalfunctionNov 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE NURSE OPENED THE PACKAGE, THE ABSORBABLE MICROHOOK FELL OFF. THE MESH WAS NOT USED IN THE ABDOMINAL CAVITY. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879742 ↗
• InjuryAug 5, 2021Migration 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 PAIN, SWELLING, SUFFERING, ADHESIONS, MESH MIGRATION, DEFECTIVE MESH, INCONTINENCE, LOSS OF CONSORTIUM, LOSS OF AMENITIES OF LIFE, LOSS OF ENJOYMENT OF LIFE, LOSS OF ABILITY TO PARTICIPATE IN SOCIAL, RECREATIONAL, HOUSEHOLD, ATHLETIC, AND OTHER ACTIVITIES ENJOYED PREVIOUSLY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, AND ANALGESICS.

  Patient problems: Adhesion(s); Emotional Changes; Incontinence; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12285369 ↗