ProGrip TEM1509GRecalls & reported problems

Summary

The FDA's MAUDE database contains 471 adverse event reports that list this exact device (DI 10884521177673), received between Sep 15, 2017 and Jun 17, 2026 — classified as 3 deaths, 462 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (211 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 471 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN & SUFFERING.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25535423 ↗
• InjuryJun 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 25477638 ↗
• InjuryJun 1, 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 BILATERAL 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 25356446 ↗
• DeathMay 15, 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 EMOTIONAL DISTRESS, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Pain; Unspecified Tissue Injury

  MAUDE report 25185993 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON POST OPERATIVE ABDOMINAL HERNIA SURGERY, THE PATIENT DEVELOPED A VERY SERIOUS ALLERGIC REACTION WHICH WAS CHARACTERIZED WITH A BRIGHT RED AND SWOLLEN ABDOMEN. THE PHYSICIAN PRESCRIBED MEDICATION TO STOP THE ALLERGY. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED PERSISTENT COMPLICATIONS, INCLUDING CHRONIC STOMACH PAIN, ABDOMINAL TIGHTNESS DESCRIBED AS FEELING LIKE SOMEONE WAS LACING THE STOMACH. DISORDERED BOWEL TRANSIT WITH CONSTIPATION AND GASTROENTERITIS-LIKE SYMPTOMS, INABILITY TO USE ABDOMINAL MUSCLES, AND FATIGUE WERE ALSO EXPERIENCED.

  Patient problems: Constipation; Fatigue; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 25096332 ↗
• InjuryMay 5, 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 FOREIGN BODY SENSATION, RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25085588 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, RECURRENCE, PAIN, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROSCOPY.

  Patient problems: Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 24942347 ↗
• InjuryApr 20, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 24927749 ↗
• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A HYSTERECTOMY OOPHORECTOMY, THERE WERE ADHESION CYST HERNIA, SEVERAL EVENTRATION AND LIPOMA OCCLUSION. THE PATIENT REPORTED PAIN, HEADACHE, MEMORY LOSS WITH LOSS OF THE THREAD OF CONVERSATION, ELECTRICAL SHOCKS, FATIGUE, BRUISING, INABILITY TO CARRY A HEAVY LOAD, INABILITY TO WALK LONG, INABILITY TO DRIVE LONG, AND DRY EYE. SURGEON NOTES LAPAROSCOPY AND IT'S OPENINGS OF SEVERAL CENTIMETERS, APPOINTMENT PAIN DOCTOR START OF PATCH TREATMENT FOR ELECTRIC SHOCKS AND REMOVAL OF PROSTHESIS. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Dry Eye(s); Easy Bruising; Fatigue; Headache; Hernia; Insufficient Information; Memory Loss/Impairment; Neuropathy; Obstruction/Occlusion; Pain; Tissue Breakdown

  MAUDE report 24877742 ↗
• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A SURGICAL REPAIR OF A LEFT INGUINAL HERNIA AND A SURGICAL REPAIR OF AN UMBILICAL EVENTRATION WITH INSERTION OF A PARIETAL PROSTHESIS, THE PATIENT REPORTED PAIN, HEADACHE, MEMORY LOSS WITH LOSS OF THE THREAD OF CONVERSATION, ELECTRICAL SHOCKS, FATIGUE, BRUISING, INABILITY TO CARRY A HEAVY LOAD, INABILITY TO WALK LONG, INABILITY TO DRIVE LONG, AND DRY EYE. SURGEON NOTES LAPAROSCOPY AND IT IS OPENINGS OF SEVERAL CENTIMETERS, APPOINTMENT PAIN DOCTOR START OF PATCH TREATMENT FOR ELECTRIC SHOCKS. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Dry Eye(s); Easy Bruising; Fatigue; Headache; Memory Loss/Impairment; Neuropathy; Pain

  MAUDE report 24877727 ↗
• InjuryApr 10, 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 RECURRENCE, PAIN, SUFFERING, LIPOMA, SCARRING, LIMITED EXERCISING, LIFTING AND ACTIVITIES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 24840123 ↗
• InjuryApr 6, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, HERNIA REPAIR, LYSIS OF ADHESIONS AND MESH REVISION.

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

  MAUDE report 24793525 ↗
• InjuryMar 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 MEDICAL TREATMENT.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 24651674 ↗
• InjuryMar 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, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICAL TREATMENT.

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

  MAUDE report 24651658 ↗
• InjuryMar 3, 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, RECURRENCE, SWELLING/ EDEMA, INFLAMMATION, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Inflammation; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 24497711 ↗
• InjuryMar 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24486331 ↗
• InjuryOct 15, 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 FOREIGN BODY SENSATION, RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23304038 ↗
• InjuryAug 22, 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 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 22873769 ↗
• InjuryAug 22, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 22873757 ↗
• DeathAug 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN, NERVE DAMAGE, RECURRENCE, EMOTIONAL HARM, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, HERNIA REPAIR WITH NEW MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

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

  MAUDE report 22857137 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DISCOMFORT, EMOTIONAL HARM, PAIN, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22794903 ↗
• InjuryAug 12, 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, ABDOMINAL PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22786500 ↗
• InjuryAug 12, 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, ABDOMINAL PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22786437 ↗
• InjuryJul 18, 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 A VENTRAL INCISIONAL 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, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, REVISION SURGERY, AND MEDICATION.

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

  MAUDE report 22549565 ↗
• InjuryJul 3, 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 ACUTE CHRONIC PAIN <(>&<)> DISCOMFORT.

  Patient problems: Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 22397542 ↗