Surgipro SMPM-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521101302), received between Apr 4, 2018 and Aug 20, 2026 — classified as 1 death, 24 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• DeathAug 20, 2026Migration or Expulsion of Device; 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 a hernia. It was reported that after implant, the patient experienced emotional distress, recurrence, death. Post-operative patient treatment included revision surgery and hernia repair with new mesh. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

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

  MAUDE report 50356559 ↗
• InjuryAug 20, 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 A INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, MESH FAILURE, PAIN, RECURRENCE, EMOTIONAL CHANGES, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL.

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

  MAUDE report 22857025 ↗
• InjuryMar 24, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ROLLED UP MESH, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21684394 ↗
• InjuryMar 24, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ROLLED UP MESH, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21683406 ↗
• InjuryJan 29, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR.

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

  MAUDE report 18597529 ↗
• InjuryMar 10, 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 DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Distress; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 16524748 ↗
• InjuryJul 29, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Fistula; Hernia; Impaired Healing; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15135223 ↗
• InjuryMar 9, 2022Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, INFLAMMATION, MESH PROTRUDING, MESH DETACHMENT, FAILURE OF MESH, MENTAL PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, DEFECTIVE MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 13710753 ↗
• InjuryFeb 23, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED NERVE ENTRAPMENT, INFLAMMATION, ADHESIONS, MESH BUNCHED UP, NERVE DAMAGE, FAILURE OF MESH, MENTAL PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, CHRONIC AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND NEURECTOMY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 13586063 ↗
• InjuryAug 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 THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, FIBROCONNECTIVE TISSUE WITH FIBROSIS, MIXED INFLAMMATION, FOREIGN BODY GIANT CELL REACTION, SWELLING, DISCOMFORT, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, LYSIS OF ADHESIONS, REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12346536 ↗
• InjuryAug 16, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, SWELLING, DIARRHEA, RECURRENCE, AND RED BLOOD IN STOOL.

  Patient problems: Abdominal Pain; Diarrhea; Hemorrhage/Blood Loss/Bleeding; Hernia; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12327827 ↗
• InjuryJul 29, 2021Migration 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 THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED MESH WADDED UP, ADHESIONS, PAIN, APONEUROSIS CONTAINING SCAR TISSUE, MESH MIGRATION, MESH EROSION, AND SPERMATIC CORD INVOLVED. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE BLOCK AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Erosion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12246967 ↗
• InjuryMay 20, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CONTRACTED MESH, MIGRATED MESH, MESH EROSION INTO VISCERA, FIBROTIC SCAR, PAIN, NERVE DAMAGE, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, REMOVAL OF STITCHES, REMOVAL OF LEFT ILIOHYPOGASTRIC/LEFT ILIOINGUINAL NERVE AND SPERMATIC CORD.

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

  MAUDE report 11861146 ↗
• InjuryApr 23, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, ADHESIONS, SCARRING OF THE INGUINAL FLOOR AND CORD STRUCTURES, AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Abnormal scarring; Adhesion(s); Failure of Implant; Foreign Body Reaction; Hernia; Implant site sclerosis; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 11715802 ↗
• InjuryMar 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, DISCOMFORT, CONSTANT BUZZING NOISE FROM GROIN AREA. POST-OPERATIVE TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH MESH, MEDICATION.

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

  MAUDE report 11443822 ↗
• InjuryOct 13, 2020Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SCAR TISSUE, AND PAIN/SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

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

  MAUDE report 10673381 ↗
• InjuryAug 27, 2020Migration 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 AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Hernia; Injury; Seroma

  MAUDE report 10463132 ↗
• InjuryMay 19, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BUNCHED-UP MESH, NERVES ENTRAPPED, CORD ENTRAPMENT, ADHESIONS, NERVE PAIN, INFLAMMATION, RECURRENCE, NERVE DAMAGE, CHRONIC AND SEVERE PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED NEURECTOMY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; Nerve Damage; No Code Available; Numbness; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 10071093 ↗
• InjuryJan 22, 2020Adverse 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 RIGHT GROIN PAIN, ILIOINGUINAL NERVE ADHERENT TO THE MESH, FIBROADIPOSE TISSUE, AND POSTOPERATIVE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND RESECTION OF THE ILIOINGUINAL NERVE.

  Patient problems: Adhesion(s); Injury; No Code Available; Pain

  MAUDE report 9617264 ↗
• InjuryJan 20, 2020Adverse 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 MESH FAILURE, PAIN, SCAR TISSUE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MESH DISSECTED FREE FROM THE SPERMATIC CORD, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Failure of Implant; Hernia; Injury; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 9606479 ↗
• InjuryJul 21, 2019Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, PAIN, INFECTION, ABSCESS, FISTULA, RECURRENCE AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8810116 ↗
• InjuryJul 15, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; Migration or Expulsion of Device; Mechanics Altered; 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 A RECURRENT UMBILICAL AND RIGHT INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION, LACK OF INCORPORATION, CHRONIC RIGHT UPPER QUADRANT/SUBCOSTAL PAIN AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 8789392 ↗
• InjuryApr 15, 2019Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MESHOMA, FIBROSIS, INFLAMMATION, RECURRENCE, CONTRACTED MESH, ISCHEMIA, RIGHT INGUINODYNIA, MIGRATION, NERVE DAMAGE, RIGHT TESTICLE ISCHEMIC ORCHIDITIS, SEVERELY SCARRED INGUINAL CANAL, SOFT TISSUE THICKENING WITH MILD INFLAMMATORY STRANDING, RIGHT INGUINAL PAIN, AND NAUSEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, OVERLAY PATCH REMOVED AND REPLACED WITH LIGHTER MESH, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fibrosis; Hernia; Inflammation; Injury; Ischemia; Nausea; Nerve Damage; No Code Available; Pain; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8514483 ↗
• InjuryNov 12, 2018Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, AND RECURRENCE. TREATMENT PROVIDED FOR THESE CONDITIONS INCLUDE REVISION SURGERY.

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

  MAUDE report 8060297 ↗
• InjuryApr 4, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A ENDOSCOPIC REPAIR OF BILATERAL INGUINAL HERNIA REPAIR WITH MESH . HE HAD REVISION SURGERY 8 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED SURGICAL REVISION, RECURRENCE, PAIN, INFECTIONS.

  Patient problems: Adhesion(s); Discomfort; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; Nerve Damage; No Code Available; Nodule; Pain; Perforation; Seroma; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury; Vascular Dissection

  MAUDE report 7395261 ↗