Surgipro SPM-35-WRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10884521101371), received between Dec 14, 2017 and May 8, 2025 — classified as 81 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (51 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 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, PAINFUL ERECTION, AND PAINFUL URINATION.

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

  MAUDE report 21990258 ↗
• InjuryJan 24, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ADHESIONS, DISCOMFORT, INFLAMMATION, RECURRENCE, EMOTIONAL DISTRESS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 21233177 ↗
• InjuryDec 10, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, RECURRENCE, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 20894001 ↗
• InjuryJun 8, 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, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, SCAR TISSUE, DISRUPTION OF ANATOMY BY MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENTTREATMENT INCLUDED PARTIAL REMOVAL OF MESH.

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

  MAUDE report 17088653 ↗
• InjuryJun 8, 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, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, SCAR TISSUE, DISRUPTION OF ANATOMY BY MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH.

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

  MAUDE report 17088030 ↗
• InjuryJun 8, 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, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, SCAR TISSUE, DISRUPTION OF ANATOMY BY MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENTTREATMENT INCLUDED PARTIAL REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 17087997 ↗
• InjuryMay 17, 2023Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, MESH MIGRATION, DEFECTIVE MESH, PAIN, INFLAMMATION, RECURRENCE, FOREIGN BODY REACTION, FISTULA, DISCHARGE, SCARRING, INFECTION, NERVE DAMAGE, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, INFLAMMATION, ALLERGIC REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Emotional Changes; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16947913 ↗
• InjuryMar 24, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, FAILURE OF MESH, PAIN, DISCOMFORT, INFLAMMATION, RECURRENCE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Burning Sensation; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Fibrosis; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 16613193 ↗
• InjuryMar 24, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, FAILURE OF MESH, PAIN, DISCOMFORT, INFLAMMATION, RECURRENCE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Burning Sensation; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Fibrosis; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 16613187 ↗
• InjuryMay 3, 2022Mechanics 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, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 14269339 ↗
• InjuryApr 22, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn

  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, LACK OF INGROWTH, MENTAL PAIN, IMPAIRMENT, PAIN, SCARRING, INFLAMMATION, DISCOMFORT, IMPROPER REVASCULARIZATION, ADHESIONS, DISABILITY, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14189267 ↗
• InjuryApr 21, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, SCARRING, DISFIGUREMENT, MENTAL PAIN, PAIN, ADHESIONS, EROSION, WOUND DEHISCENCE, INFECTION, ABSCESS, MESH NOT INCORPORATED, PERMANENT PHYSICAL DEFORMITY, RECURRENCE, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF ABSCESS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Erosion; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14168609 ↗
• InjuryApr 7, 2022Adverse 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 VENTRAL AND INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, BULGE, RECURRENCE, DISCOMFORT, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION, HOSPITALIZATION.

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

  MAUDE report 14048811 ↗
• InjuryDec 7, 2021Degraded; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Deformation; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL AND PHYSICAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, INFLAMMATION, BACTERIAL INFECTION, MESH DEGRADATION, MESH DEFORMED, MESH NOT INCORPORATED, CHRONIC DRAINING ABSCESS, RECURRENCE, MESH EVENTRATION, SCAR TISSUE, PAIN, CALCIFIED NECROTIC FAT TISSUE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, HERNIA REPAIR WITH MESH, AND LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Anxiety; Bacterial Infection; Calcium Deposits/Calcification; Depression; Discomfort; Emotional Changes; Fluid Discharge; Hernia; Inflammation; Necrosis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12953372 ↗
• InjuryOct 18, 2021Degraded; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, MESH BUCKLED, MESH MIGRATION, EXCESSIVE AMOUNT OF ADIPOSE TISSUE, DISCOMFORT, DIASTASIS, CLUMPED UP MESH, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH MESH.

  Patient problems: Abscess; Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Emotional Changes; Fluid Discharge; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 12651228 ↗
• 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 VENTRAL 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 12450853 ↗
• InjurySep 2, 2021Degraded; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Deformation; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, BACTERIAL PROLIFERATION, INFECTION, MESH DEGRADATION, MESH ENCASED IN BIOFILM, MESH DEFORMED, MESH NOT INCORPORATED, CHRONIC DRAINING ABSCESS, DEFECTIVE DEVICE, RECURRENCE, MENTAL AND PHYSICAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, NERVE INJURY, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PAIN MEDICATIONS FOR THREE WEEKS. IT WAS NOTED THAT THE MESH WAS UNABLE TO BE REMOVED DUE TO HIGH RISK.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Nerve Damage; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12417510 ↗
• 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, BLEEDING VESSEL/OOZING THROUGHOUT WOUND, HEMATURIA, OPEN WOUND, BULGE, HEMATOMA, AND ACTIVE BLEEDING IN INTERNAL OBLIQUE MUSCLE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EVACUATION OF RIGHT GROIN HEMATURIA, WOUND EXPLORATION, WOUND VAC, HERNIA REPAIR WITH NEW MESH, MESH DISSECTED OFF EXTERNAL OBLIQUE APONEUROSIS, SECURE LIGATION OF BLEEDING VESSEL AND INTERNAL OBLIQUE MUSCLE, AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Hematoma; Hematuria; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Unspecified Tissue Injury

  MAUDE report 12324643 ↗
• InjuryJul 30, 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 PAIN AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND MESH REMOVAL.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 12254022 ↗
• InjuryJul 15, 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 AND INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE ADHESIONS, HERNIA RECURRENCE, BURNING SENSATION, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND MESH REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Burning Sensation; Diarrhea; Discomfort; Emotional Changes; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12178667 ↗
• InjuryJul 15, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, INFECTION, ABSCESS, SEVERE PAIN, SCARRING, CHRONIC INFLAMMATION, SINUS TRACTS, UNINCORPORATED MESH, FAILURE OF MESH, AND CHRONIC TISSUE GRANULATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERIES, DEBRIDEMENT OF NONHEALING WOUND AND SINUS TRACTS, AND ORCHIECTOMY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Impaired Healing; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12178044 ↗
• InjuryJul 15, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, INFECTION, ABSCESS, SEVERE PAIN, SCARRING, CHRONIC INFLAMMATION, SINUS TRACTS, UNINCORPORATED MESH, FAILURE OF MESH, HERNIA RECURRENCE, NONHEALING WOUND, AND CHRONIC TISSUE GRANULATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERIES, HERNIA REPAIR WITH MESH, DEBRIDMENT OF NONHEALING WOUND AND SINUS TRACTS, AND ORCHIECTOMY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Hernia; Impaired Healing; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12177885 ↗
• InjuryJul 15, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, INFECTION, ABSCESS, SEVERE PAIN, SCARRING, CHRONIC INFLAMMATION, SINUS TRACTS, UNINCORPORATED MESH, FAILURE OF MESH, HERNIA RECURRENCE, NONHEALING WOUND, AND CHRONIC TISSUE GRANULATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERIES, HERNIA REPAIR WITH MESH, DEBRIDMENT OF NONHEALING WOUND AND SINUS TRACTS, AND ORCHIECTOMY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Hernia; Impaired Healing; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12177863 ↗
• InjuryJul 15, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 12173639 ↗
• InjuryJun 25, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, SCAR TISSUE, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INJECTIONS, DIAGNOSTIC LAPAROSCOPY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND PHYSICAL THERAPY.

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

  MAUDE report 12068037 ↗