ProGrip PP1208DLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521177659), received between Dec 6, 2019 and Apr 21, 2026 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 11 most recent of 11 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 PE

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

  MAUDE report 24935943 ↗
• MalfunctionMar 13, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER AN INGUINAL HERNIA ON THE LEFT SIDE, THE PATIENT WAS EXPERIENCING PAIN IN THE GROIN AND A SEVERE BURNING SENSATION IN THE PUBIC AREA. THERE WAS A CONSTANT PAIN EVEN WITHOUT TOUCHING. DISCOMFORT WHEN WALKING. A SITUATION THAT IMPACTED EVERYDAY LIFE AND INDUCED CONCERN FOR THE FUTURE. CONSULTATION WITH THE GENERAL PRACTITIONER WHO HAS PRESCRIBED AN ULTRASOUND, WHO FOUND THE MESH NORMALLY IN PLACE. CONSULTATION THEN WITH THE SURGEON, WHO NOTICED NOTHING ABNORMAL AND REFERRED THE PATIENT TO A PAIN CENTER.

  Patient problems: Discomfort; Pain

  MAUDE report 24596127 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MESH WAS IMPLANTED DURING A LEFT INGUINAL HERNIA REPAIR USING THE LICHTENSTEIN TECHNIQUE. THE PROCEDURE INVOLVED A HORIZONTALIZED LEFT INGUINAL INCISION UNDER LOCOREGIONAL ANESTHESIA, OPENING OF THE FASCIA OF THE GREAT OBLIQUE, DISSECTION OF THE CORD, RESECTION OF AN EXTERNAL OBLIQUE HERNIA SAC WITH PERITONEAL CLOSURE, PLACEMENT AND FIXATION OF THE PROSTHETIC PLATE, AND CLOSURE OF THE FASCIA AND SKIN. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PERMANENT STRETCHING SENSATIONS ON THE LEFT OPERATED SIDE, SENSATIONS OF SWELLING THAT WERE FLAT TO THE TOUCH, BURNING SENSATION IN THE URETHRA WHEN EJACULATING, RAPID AND INTENSE PAIN WHEN EJACULATING, A FEELING OF HAVING TO URINATE WITH SLIGHT PAIN IN THE PROSTHESIS AREA DESPITE AN EMPTY BLADDER, AND CONSTIPATION RELIEVED BY MASSAGING AT THE LEVEL OF THE SCAR WITH AN ASSOCIATED FEELING OF SWELLING. THE PATIENT ALSO REPORTED AN INABILITY TO WEAR A TIGHT PANTS BELT WITHOUT PAIN AND APPARENT SWELLING AT THE LOWER ABDOMEN ON THE LEFT SIDE. THERE WAS A TEMPORARY PENIS DEFORMITY AFTER THE OPERATION, WHICH RESOLVED SPONTANEOUSLY, AND INTERMITTENT PAIN ON THE OPERATION SIDE DURING THE DAY FOR NO APPARENT REASON. IT WA

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Deformity/ Disfigurement; Dysuria; Pain; Sexual Dysfunction; Swelling/ Edema; Urinary Frequency / Polyuria

  MAUDE report 24421560 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, AFTER TWO OPERATIONS FOR THE INSTALLATION OF INGUINAL PROSTHESES, THE PATIENT HAS BEEN DISABLED FOR SIX YEARS. IN ADDITION, THE PATIENT HAD PAIN, CHRONIC INFLAMMATION, AND OTHER RELATED HEALTH PROBLEMS LIKE NEUROPATHICDAMAGE, PERICARDITIS, TIETZE SYNDROME AND A TOTALLY DEGRADED QUALITY OF LIFE.

  Patient problems: Neuropathy; Pain; Pericarditis

  MAUDE report 22563051 ↗
• 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 21807940 ↗
• MalfunctionSep 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA PROCEDURE VIA LICHTENSTEIN TECHNIQUE, BEFORE USING THE DEVICE ON PATIENT, IT WAS DISCOVERED THAT THE MESH WAS DAMAGED AFTER OPENING THE PACKAGE. THE PRODUCT WAS NOT IMPLANTED TO THE PATIENT. A NEW MESH WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15489152 ↗
• MalfunctionMar 17, 2022Packaging Problem; Material Split, Cut or Torn; Packaging Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO A LICHTENSTEIN GROIN HERNIA PROCEDURE, BEFORE THE PACKAGING WAS OPENED, THE FLAP WAS NOT FIX TO THE REST OF THE MESH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790807 ↗
• MalfunctionNov 3, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LICHTENSTEIN HERNIA PROCEDURE, THE BROKEN MESH WAS DETECTED WHEN IT WAS OPENED AT THE TABLE. IT WAS STATED THAT THE FLAP ON THE SUPERIOR SIDE OF THE MESH WAS NOT ATTACHED TO THE REST OF THE MESH. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10778499 ↗
• MalfunctionJun 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE ON AN INGUINAL HERNIA REPAIR PROCEDURE, AFTER OPENING THE PACKAGE, THE MESH'S FLAP WAS NOTICED TO BE TORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10181511 ↗
• InjuryJan 28, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL IMPLANT.

  Patient problems: Emotional Changes; Hernia; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 9639107 ↗
• MalfunctionDec 6, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING FIXATION OF THE MESH ON AN OPEN INGUINAL LEFT REPAIR PROCEDURE, WHEN THE SURGEON PUT THE SUTURE THROUGH THE MESH, IT BROKE AT THE JUNCTION OF THE FLAP. ANOTHER MESH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432840 ↗