ProGrip TEM1409GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521177710), received between Dec 21, 2017 and Mar 11, 2026 — classified as 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (22 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryMar 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BILATERAL GROIN CYST, ABSCESS, PAIN, SUFFERING, BILATERAL GROIN SINUSES AND DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION AND EXCISION OF BILATERAL GROIN CYST.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Fluid Discharge; Pain; Unspecified Tissue Injury

  MAUDE report 24570414 ↗
• InjuryFeb 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 24371089 ↗
• InjuryFeb 3, 2026Migration or Expulsion of Device; 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 RECURRENCE, MESH MIGRATION, PAIN AND SUFFERING.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24250924 ↗
• InjuryJan 5, 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 DEPRESSION, ANXIETY, LIMITED PHYSICAL MOBILITY, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23963628 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, BEFORE APPLYING TO THE INGUINAL LIGAMENT, THE TWO MESH WAS FOUND TO BE RIPPED AFTER OPENING THE PACKAGING. A NEW MESH WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891468 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, BEFORE APPLYING TO THE INGUINAL LIGAMENT, THE TWO MESH WAS FOUND TO BE RIPPED AFTER OPENING THE PACKAGING. A NEW MESH WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891461 ↗
• InjuryJul 17, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Emotional Changes; Hernia; No Clinical Signs, Symptoms or Conditions; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22538380 ↗
• InjuryJul 3, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 MOVEMENT, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22400112 ↗
• InjuryApr 21, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A DOUBLE INGUINAL OPERATION, A MESH WAS IMPLANTED AND POST-OPERATIVE COMPLICATIONS AROSE. THE PATIENT EXPERIENCED REPEATED CRURALGIA, DIFFUSE NERVE PAIN AROUND THE OPERATED AREA AND LOSS OF SENSATION IN THE FOOT. THERE WAS AN INABILITY TO RESUME NORMAL PHYSICAL ACTIVITY DUE TO A PERMANENTLY CONTRACTED PSOAS AND MUSCULAR CONSEQUENCES ON THE RIGHT LEG, ALONG WITH A VERY DETERIORATED PSYCHOLOGICAL STATE. THE MESH REPORTEDLY HEALED POORLY AND MOVED ONTO THE FEMORAL BONE AND TESTICULAR CORD, LEADING TO A LACK OF BLOOD SUPPLY TO THE TESTICLE, NECESSITATING EMERGENCY SURGERY. DURING THE SURGERY, THE TESTICLE WAS FOUND TO BE HEMORRHAGING WITH NECROSIS AROUND IT. SUBSEQUENT EXAMINATIONS REVEALED A LESION OF THE CRURAL NERVE UNDER THE AREA OPERATED ON FOR THE INGUINAL HERNIA AND SUBNORMAL BLOOD FLOW IN THE FEMORAL REGION. DESPITE TREATMENT, ATTACKS OF CRURALGIA AND MUSCULAR PAIN IN THE PSOAS AND ADDUCTOR MAGNUS WORSENED. THE PATIENT UNDERWENT PHYSIOTHERAPY FOR THE PSOAS AND RECEIVED ANTI-INFLAMMATORIES AND REST FOR CRURALGIA. AN ELECTROMYOGRAM WAS CONDUCTED, CONFIRMING THE NERVE LESION. THE PATIENT SUSTAINED PERMANENT INJURIES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inadequate Pain Relief; Laceration(s); Myalgia; Necrosis

  MAUDE report 21873468 ↗
• InjuryAug 9, 2024Mechanics 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 REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19954983 ↗
• InjuryApr 26, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 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 HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19192138 ↗
• InjuryOct 20, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, SCARRING, DISCOMFORT, DISFIGUREMENT, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17979754 ↗
• InjuryFeb 7, 2023Mechanics 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 FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16313618 ↗
• InjuryJan 19, 2023Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HYDROCELE, MESH FAILED, RECURRENCE, DEFECTIVE DEVICE, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16212264 ↗
• InjuryJan 19, 2023Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH FAILED, RECURRENCE, DEFECTIVE DEVICE, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16211001 ↗
• InjuryJan 13, 2023Adverse 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ILEUS, ELEVATED WHITE BLOOD CELLS, DECREASED HEMOGLOBIN AND HEMATOCRIT, PAIN, RECURRENCE, ADHESIONS, AND OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, RIGHT GROIN EXPLORATION, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, RIGHT INGUINAL HERNIA REPAIR, & IV ANTIBIOTICS.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 16157693 ↗
• InjurySep 7, 2022Mechanics 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, SUFFERING, GROIN PAIN, ADHESIONS, SPERMATIC CORD INVOLVEMENT, RECURRENCE, INFLAMMATION, NERVE DAMAGE, LIMITED MOBILITY, MESH FAILURE, DEVICE DEFECTIVE, SCARRING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, & HERNIA REPAIR.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Cramp(s) /Muscle Spasm(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15375549 ↗
• InjuryJun 9, 2022Migration 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, DEFECTIVE DEVICE, MESH FAILURE, SCARRING, MENTAL PAIN, SUFFERING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 14646944 ↗
• InjuryFeb 28, 2022Mechanics 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 HERNIA. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF ABDOMINAL PAIN, ABSCESS, SCARRING, INFECTION, NERVE DAMAGE, INFLAMMATION, PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, DEFECTIVE MESH, AND MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Abscess; Emotional Changes; Impaired Healing; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13620006 ↗
• InjuryDec 7, 2021Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILED, MESH SHRINKAGE, RECURRENCE, ADHESIONS, DEFECTIVE DEVICE, MENTAL AND PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND MESH REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Ischemia; Nodule; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12950279 ↗
• InjurySep 9, 2021Adverse 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 CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 12448134 ↗
• InjuryAug 16, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BLEEDING, MESH MIGRATION, SPERMATIC CORD SKELETONIZED WITHOUT BLOOD SUPPLY, AND BRADYCARDIAC EVENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, LIGATION OF SPERMATIC CORD, AND EXPLANT OF MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bradycardia; Hemorrhage/Blood Loss/Bleeding; Hernia; Unspecified Tissue Injury

  MAUDE report 12324612 ↗
• InjuryJul 2, 2021Mechanics 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ACUTE URINARY RETENTION, SCROTAL EDEMA, HEMATOMA, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ORCHIECTOMY, REVISION SURGERY, AND HERNIA REPAIR WITH MESH.

  Patient problems: Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hernia; Impaired Healing; Inflammation; Ischemia; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 12109558 ↗
• InjuryMay 20, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INGUINAL PAIN, INGUINAL NERVE PAIN, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 11861168 ↗
• InjuryMay 20, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 THE IMPLANT, THE PATIENT EXPERIENCED MESH WRAPPED AROUND CORD STRUCTURES, ADHESIONS, RECURRENCE, SCARRING, PAIN, BLEEDING, SPERMATIC CORD INVOLVEMENT, MESH MIGRATION, INCARCERATED SMALL BOWEL, AND BOWEL CONSTIPATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Constipation; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11861156 ↗