ProGrip TEM1208GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 10884521177697), received between Apr 27, 2017 and Aug 12, 2026 — classified as 385 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (157 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 25 most recent of 406 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Discomfort; Pain

  MAUDE report 50218628 ↗
• InjuryJul 31, 2026Adverse 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 inguinal hernia. It was reported that after the implant, the patient experienced inflammatory mass, lower abdominal wall weakness, pain, inflammation, allergic reaction, adhesions, neuroma, <(>&<)> numbness. Post-operative patient treatment included mesh removal, removal of mass, resection of ilioinguinal nerve, reinforcement of lower abdominal wall, <(>&<)> medication.

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; Inflammation; Muscle Weakness/Atrophy; Nodule; Numbness; Pain; Unspecified Tissue Injury

  MAUDE report 50094206 ↗
• InjuryJul 27, 2026Adverse 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, recurrence, adhesions, nerve damage. Post-operative patient treatment included medication.

  Patient problems: Adhesion(s); Hernia; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 50020119 ↗
• InjuryMay 12, 2026Adverse 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 IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN AND SUFFERING.

  Patient problems: Distress; Pain; Unspecified Tissue Injury

  MAUDE report 25153201 ↗
• MalfunctionApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE TO A RIGHT INGUINAL HERNIA SURGERY, THE PATIENT HAD PERSISTENT PAIN THAT GRADUALLY WORSENED OVER TIME AND BECAME PERMANENT WITH INCREASING INTENSITY. TIGHTNESS AND A BURNING SENSATION WERE REPORTED, ALONG WITH PAIN ON TOUCH IN THE GROIN, THIGH PAIN, LOWER BACK PAIN, AND DISCOMFORT AND PAIN AROUND THE PUBIS, WITH PAIN DESCRIBED AS PREDOMINANT ON THE RIGHT SIDE. SITTING POSITION COULD NOT BE MAINTAINED FOR MORE THAN AN HOUR DUE TO GROIN PAIN. SLEEP DISTURBANCE WAS REPORTED WITH SLEEP LIMITED TO AN AVERAGE OF FIVE HOURS PER NIGHT, ALONG WITH CHRONIC FATIGUE. PAINFUL SEXUAL INTERCOURSE WAS REPORTED DUE TO PERMANENT PAIN LOCALIZED IN THE PUBIC AREA.

  Patient problems: Back pain; Burning Sensation; Discomfort; Fatigue; Limb Pain; Pain; Sexual Dysfunction; Sleep Dysfunction

  MAUDE report 25045694 ↗
• InjuryApr 21, 2026Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 24942885 ↗
• InjuryApr 11, 2026Adverse 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 PAIN, NERVE DAMAGE, RECURRENCE, SWELLING, NERVE PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Discomfort; Hernia; Nerve Damage; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 24852254 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, SPERMATIC CORD INVOLVEMENT, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TESTICLE REMOVED.

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

  MAUDE report 24783530 ↗
• InjuryApr 2, 2026Adverse 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, HARD TO SLEEP, SWELLING, IRRITATION.

  Patient problems: Discomfort; Pain; Skin Inflammation/ Irritation; Sleep Dysfunction; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 24772201 ↗
• InjuryMar 12, 2026Adverse 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 EMOTIONAL DISTRESS, PAIN, ADHESIONS, RECURRENCE, SEXUAL DYSFUNCTION.

  Patient problems: Adhesion(s); Distress; Hernia; Pain; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 24581231 ↗
• MalfunctionMar 5, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA REPAIR, A LICHTENSTEIN APPROACH, WHEN THE MESH WAS OPENED PRIOR TO PATIENT USE, THE MESH CAME IN TWO PIECES; THE MESH FLAP AND THE REST OF THE MESH. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524598 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE CURE OF A STRANGULATED RIGHT INGUINAL HERNIA BY INGUINAL APPROACH WITH MISE IN PLACE OF PROSTHESIS UNDER GENERAL ANESTHESIA, THE PATIENT EXPERIENCED THE APPEARANCE OF VERY LARGE PURPLISH SKIN RASHES ALL OVER THE BODY, REGULAR FEVER (38/39°C), VIOLENT ABDOMINAL PAIN THAT MADE MOVEMENT IMPOSSIBLE WITHOUT ASSISTANCE, INFLAMMATION OF ALL LYMPH NODES, GREAT FATIGUE, LOSS OF EIGHT KILOGRAMS IN WEIGHT, HEADACHES, AND GENERAL PHYSICAL, PSYCHOLOGICAL, AND MORAL EXHAUSTION. BLOOD TESTS SHOWED HIGH INFLAMMATORY SIGNS, INCLUDING ELEVATED PLATELETS (414 G/L), FIBRINOGEN (5.25 G/L), C-REACTIVE PROTEIN (CRP) (35.8 MG/L), TRIGLYCERIDES (1.72 MMOL/L), FERRITIN (2578.0 ¿G/L) , ALANINE AMINOTRANSFERASE (ALT) (82 IU/L), ASPARTATE AMINOTRANSFERASE (AST) (60 IU/L), AND LACTIC ACID DEHYDROGENASE (584 IU/L). LIVER DYSREGULATION WAS NOTED. THE PATIENT REPORTED UNBEARABLE AND DISABLING PAIN, ITCHY SKIN RASHES DAY AND NIGHT, LOSS OF AUTONOMY, AND LOSS OF EMPLOYMENT. HOSPITALIZATION LASTED FOR TWO MONTHS, AND AFTER RETURNING HOME AT THE BEGINNING OF (B)(6) 2025, THE PATIENT REMAINED UNABLE TO RESUME PROFESSIONAL ACTIVITY.

  Patient problems: Abdominal Pain; Fatigue; Fever; Headache; Inflammation; Liver Damage/Dysfunction; Rash; Weight Changes

  MAUDE report 24255119 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 24121095 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 24119130 ↗
• InjuryDec 30, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 UMBILICAL AND BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, SEROMA, NON-HEALING ABDOMINAL WOUND, ABDOMINAL DISTENTION, ABSCESS, NUMBNESS IN ABDOMEN AND GROIN, DEFECTIVE MESH, FAILURE OF MESH, CHRONIC WOUND, ADHESIONS, INFECTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REMOVAL OF MESH, EXCISION OF CHRONIC WOUND, DEBRIDEMENT OF ABDOMINAL SKIN, WOUND VAC, LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Emotional Changes; Hernia; Impaired Healing; Inflammation; Numbness; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23926651 ↗
• MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRE-OPERATIVELY, AFTER OPENING THE PACKAGING, THE MESH WAS FOUND TO BE TORN BEFORE IT COULD BE USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829772 ↗
• InjuryDec 12, 2025Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, MESH BALLED, MESH EVENTRATION, INFLAMMATION, RECURRENCE, PAIN, BOWEL ISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Inflammation; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 23791313 ↗
• InjuryDec 1, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23688593 ↗
• InjuryNov 25, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, PERFORATION, ABSCESS, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, SMALL BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Discomfort; Hypersensitivity/Allergic reaction; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23649305 ↗
• InjuryNov 20, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, ABDOMINAL DISTENTION, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Hernia; Inflammation; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 23610988 ↗
• InjuryNov 20, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, ABDOMINAL DISTENTION, NERVE DAMAGE. PO ST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Hernia; Inflammation; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 23610874 ↗
• InjuryNov 7, 2025Adverse 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 implant, the patient experienced emotional distress, hernia recurrence, pain, suffering, <(>&<)> nerve damage. Post-operative patient treatment included revision surgery, mesh removal, hernia repair with mesh, <(>&<)> hernia repair.

  Patient problems: Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 23500480 ↗
• InjuryAug 8, 2025Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 CORD LIPOMA, RECURRENCE, PAIN, SUFFERING, BLEEDING, BOWEL PROBLEMS, EMOTIONAL PROBLEMS, EXPOSURE/EXTRUSION/PROTRUSION, INFLAMMATION, & INCISION SITE OPENING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, & HERNIA REPAIR.

  Patient problems: Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nodule; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 22751061 ↗
• InjuryAug 5, 2025Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, NEURALGIA, AND TENDERNESS.

  Patient problems: Discomfort; Hernia; Inflammation; Neuralgia; Pain; Unspecified Tissue Injury

  MAUDE report 22722185 ↗
• InjuryJul 17, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 22538421 ↗