Surgipro SPMM-66Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10884521101449), received between Apr 19, 2017 and Feb 28, 2024 — classified as 58 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (21 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, SEPARATION OF COMPONENTS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18803301 ↗
• InjuryApr 6, 2023Migration 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH EXTRUSION, DEFECTIVE MESH, PAIN, RECURRENCE, INFECTION, GRANULOMA, SCARRING, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR.

  Patient problems: Adhesion(s); Emotional Changes; Granuloma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16691855 ↗
• InjuryMar 10, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, HERNIA RECURRENCE AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC AND MEDICATION.

  Patient problems: Abscess; Hernia; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16522886 ↗
• InjuryJan 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH BUNCHED UP, FAILURE OF MESH, PAIN, MENTAL PAIN, DISABILITY, RECURRENCE, SCARRING, INFLAMMATION, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, REMOVAL OF MESH.

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

  MAUDE report 16186621 ↗
• InjuryJun 9, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, INJURY, DEFECTIVE DEVICE, MESH FAILURE, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

  Patient problems: Adhesion(s); Emotional Changes; Failure of Implant; Incontinence; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 14646374 ↗
• InjurySep 9, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, MESH SHRINKAGE, ATTENUATED FASCIA, AND MESH FOLDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Muscle Weakness/Atrophy; Unspecified Tissue Injury

  MAUDE report 12448273 ↗
• InjurySep 9, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, MESH SHRINKAGE, ATTENUATED FASCIA, AND MESH FOLDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Muscle Weakness/Atrophy; Unspecified Tissue Injury

  MAUDE report 12448230 ↗
• InjurySep 6, 2021Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, MESH CONTRACTION, EXTENSIVE ADHESIONS, ADHESIONS TO MESH, LIVER, THE OMENTUM, SMALL INTESTINE AND SIGMOID COLON, MESH FAILURE, PAIN, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY, AND MESH REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Emotional Changes; Eructate; Failure of Implant; Fistula; Flatus; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12431060 ↗
• InjuryAug 5, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, INJURIES, PRODUCT DEFECT, A LOSS OF ENJOYMENT OF LIFE, LOSS THE ABILITY TO PARTICIPATE IN HER USUAL SOCIAL, RECREATIONAL, HOUSEHOLD, ATHLETIC, AND OTHER ACTIVITIES ENJOYED PREVIOUSLY, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, AND REST.

  Patient problems: Abscess; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Confusion/ Disorientation; Emotional Changes; Fistula; Fluid Discharge; Fungal Infection; Hallucination; Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Sepsis; Swelling/ Edema; Tachycardia; Thrombosis/Thrombus; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12281650 ↗
• InjuryJul 29, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL AND REVISION SURGERY.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 12247041 ↗
• 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTION, SEROMA, ABSCESS, SEVERE AND CHRONIC ABDOMINAL PAIN, 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 Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Emotional Changes; Fluid Discharge; Inflammation; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12178784 ↗
• InjuryMay 21, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HETEROGENEOUSLY HYPOECHOIC RIGHT TESTICLE, HYDROCELE, LESION, MASS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, RIGHT ILIOINGUINAL NEURECTOMY, AND RESECTION OF RIGHT SCROTAL LESION.

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

  MAUDE report 11867283 ↗
• 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HETEROGENEOUSLY HYPOECHOIC RIGHT TESTICLE, HYDROCELE, LESION, MASS, RECURRENCE, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH AND ROLLED UP MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, RIGHT ILIOINGUINAL NEURECTOMY, MESH REMOVAL AND RESECTION OF RIGHT SCROTAL LESION.

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

  MAUDE report 11861173 ↗
• InjuryMay 18, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH DETACHMENT, OPEN DRAINING WOUND, SEROMA, INFECTION, EXPOSED MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Fluid Discharge; Hernia; Impaired Healing; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11846160 ↗
• InjuryApr 8, 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 VENTRAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND AVULSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MESH REMOVAL.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11634682 ↗
• InjuryApr 1, 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11602349 ↗
• InjuryMar 20, 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 ADHESIONS, RECURRENCE, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, AND MESH REMOVAL.

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

  MAUDE report 11536659 ↗
• InjuryMar 5, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DEBRIDEMENT, PLACEMENT OF VAC SPONGE, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11420637 ↗
• InjuryFeb 1, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Integrity Problem; 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 TWO INCARCERATED VENTRAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, MESH MIGRATION, MESH CONTRACTION, PAIN, ABDOMINAL PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Distress; Failure of Implant; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 11259414 ↗
• InjuryJan 5, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH TORN, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 11116416 ↗
• InjuryNov 30, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND MESH WADDED UP. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND IMPLANTATION OF AN ADDITIONAL MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 10922887 ↗
• InjuryOct 9, 2020Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, RECURRENCE, SEVERE PAIN, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PERITONEUM AND OLD MESH CLOSED WITH SUTURE, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10657850 ↗
• InjurySep 23, 2020Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, RECURRENCE, ADHESIONS, PAIN, INFLAMMATION, MESH MIGRATION, FAILURE OF MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH INTERVENTION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Emotional Changes; Hernia; Inflammation; Injury; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10575902 ↗
• InjurySep 21, 2020Mechanics 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY, REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Emotional Changes; Fluid Discharge; Hernia; Inflammation; Injury; Pain; Perforation; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 10564074 ↗
• InjurySep 8, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, ADHESIONS, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF INFECTED MESH, LYSIS OF ADHESIONS, WOUND VAC, AND IMPLANTATION OF AN ADDITIONAL MESH PRODUCT.

  Patient problems: Adhesion(s); Hernia; Impaired Healing; Injury; Pain; Unspecified Infection

  MAUDE report 10504956 ↗