Surgipro SPMM-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10884521101425), received between May 2, 2017 and Jan 17, 2025 — classified as 76 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (26 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 79 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21185478 ↗
• InjuryJun 30, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 17237544 ↗
• InjuryDec 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENTS.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 15965029 ↗
• InjuryMay 20, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, RECURRENCE, LOSS OF ENJOYMENT OF LIFE, INABILITY TO PARTICIPATE IN ACTIVITIES, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, HOSPITALIZATION, IMAGING REQUIRED, REHABILITATION, PHYSIOTHERAPY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cellulitis; Emotional Changes; Erythema; Fever; Fluid Discharge; Foreign Body Reaction; Hernia; Hypoxia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14459468 ↗
• InjuryApr 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, RECURRENCE, LOSS OF ENJOYMENT OF LIFE, INABILITY TO PARTICIPATE IN USUAL ACTIVITIES, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, HOSPITALIZATION, REHABILITATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14049015 ↗
• InjuryJan 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, HERNIA RECURRENCE, MESH ADHESIONS, BOWEL COMPLICATIONS, SCARRING, DISFIGUREMENT, DEFECTIVE DEVICE, PSYCHOLOGICAL/EMOTIONAL INJURIES, LOSS OF ENJOYMENT OF LIFE, PERMANENT PHYSICAL DISABILITY, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13385974 ↗
• 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 12449006 ↗
• InjurySep 2, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE SCARRING, HERNIA RECURRENCE, MESH PUSHED ASIDE BY HERNIA, PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Pain; Peritonitis; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 12418988 ↗
• InjuryJul 8, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, FLUID COLLECTION, DISCOMFORT, BULGE, ADHESIONS, INDURATION, PURULENT MATERIAL, MASS, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, LYSIS OF ADHESIONS, APPENDECTOMY, BIOPSY OF SMALL BOWEL MASS, BIOPSY OF MESENTERIC MASS, BIOPSY OF PERITONEAL IMPLANT, RECONSTRUCTION OF THE ABDOMINAL WALL, AND REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Failure of Implant; Hernia; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 12136346 ↗
• InjuryJun 25, 2021Degraded; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 ABDOMINAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL ANGUISH, EMOTIONAL DISTRESS, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRED AND CONTRACTED MESH, SEROSAL TEAR, INFECTION, SEROMA, CHRONIC HEMATOMAS, FLUID COLLECTION, ADHESIONS, HERNIA RECURRENCE, FEVER, ABDOMINAL PAIN, CHRONIC PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, DRAINAGE OF HEMATOMA, LYSIS OF ADHESIONS, REMOVAL OF MESH, AND INCISION AND DRAINAGE OF FLUID COLLECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Distress; Emotional Changes; Fever; Fistula; Hematoma; Hernia; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12066835 ↗
• InjuryJun 18, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTED MESH, PURULENT MATERIAL, MESH EROSION, MESH NOT ATTACHED/FREE FLOATING, SCARRING, ESCHERICHIA COLI, FISTULA, GRANULATION TISSUE, CELLULITIS, STAPHYLOCOCCUS AUREUS, DENSE INFLAMMATORY REACTION, OBLITERATION OF THE NORMAL PLANES, SPERMATIC CORD INVOLVED, MESH MIGRATION, ADHESIONS, OPEN WOUND, SINUS DRAINAGE, BLEEDING, NONVIABLE SUBCUTANEOUS TISSUE, INFLAMMATION, SCAR TISSUE, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION/DRAINAGE OF ABSCESS, REMOVAL OF MESH, PURULENT MATERIAL EXPRESSED, LAVAGE WITH SALINE AND BETADINE, WOUND DEBRIDEMENT, WOUND WAS IRRIGATED, FASCIAL DEFECT WAS LOOSELY REAPPROXIMATED AT THE SITE OF THE PLUG WITH SUTURES, WOUND VAC, OPEN WOUND WAS THEN COPIOUSLY IRRIGATED, ELLIPTICAL INCISION AND SUBCUTANEOUS DISSECTION, SKIN/NONVIABLE SUBCUTANEOUS TISSUE/SOME EXTERNAL OBLIQUE FASCIA WAS EXCISED, BLEEDING CONTROLLED WITH LIGATURES OF SILK, HEMOSTASIS WAS ACHIEVED WITH ELECTROCAUTERY, LYSIS OF ADHESIONS, PORTIONS OF M

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Erosion; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12026144 ↗
• InjuryJun 18, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTED MESH, PURULENT MATERIAL, MESH EROSION, MESH NOT ATTACHED/FREE FLOATING, SCARRING, ESCHERICHIA COLI, FISTULA, GRANULATION TISSUE, CELLULITIS, STAPHYLOCOCCUS AUREUS, DENSE INFLAMMATORY REACTION, OBLITERATION OF THE NORMAL PLANES, SPERMATIC CORD INVOLVED, MESH MIGRATION, ADHESIONS, OPEN WOUND, SINUS DRAINAGE, BLEEDING, NONVIABLE SUBCUTANEOUS TISSUE, INFLAMMATION, SCAR TISSUE, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION/DRAINAGE OF ABSCESS, REMOVAL OF MESH, PURULENT MATERIAL EXPRESSED, LAVAGE WITH SALINE AND BETADINE, WOUND DEBRIDEMENT, WOUND WAS IRRIGATED, FASCIAL DEFECT WAS LOOSELY REAPPROXIMATED AT THE SITE OF THE PLUG WITH SUTURES, WOUND VAC, OPEN WOUND WAS THEN COPIOUSLY IRRIGATED, ELLIPTICAL INCISION AND SUBCUTANEOUS DISSECTION, SKIN/NONVIABLE SUBCUTANEOUS TISSUE/SOME EXTERNAL OBLIQUE FASCIA WAS EXCISED, BLEEDING CONTROLLED WITH LIGATURES OF SILK, HEMOSTASIS WAS ACHIEVED WITH ELECTROCAUTERY, LYSIS OF ADHESIONS, PORTIONS OF M

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Erosion; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12025518 ↗
• 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 THERAPEUTIC TREATMENT OF AN INCARCERATED VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION SURGERY.

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

  MAUDE report 11867122 ↗
• InjuryMay 18, 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 RECURRENCE, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION SURGERY.

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

  MAUDE report 11846128 ↗
• InjuryMay 17, 2021Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 HERNIA RECURRENCE, MESH CONTRACTION, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION SURGERY.

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

  MAUDE report 11833018 ↗
• InjuryMay 6, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 11786443 ↗
• InjuryApr 23, 2021Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, HERNIA RECURRENCE, SPERMATIC CORD ATTACHMENT, FIBROSIS, SCARRING, MESH FAILURE, AND MESH PROTRUSION THROUGH INGUINAL FLOOR. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY AND REVISION SURGERY WITH SPERMATIC CORD/INGUINAL LIGAMENT DISSECTION.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Failure of Implant; Fibrosis; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11716957 ↗
• 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, AND SMALL BOWEL RESECTION.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 11606248 ↗
• InjuryMar 8, 2021Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; 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 GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, INFLAMMATION, RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 11434965 ↗
• InjuryFeb 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION, BOWEL INVOLVEMENT, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 11284980 ↗
• InjuryFeb 2, 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 UMBILICAL HERNIA AND AN EPIGASTRIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, RECURRENCE, PERSISTENT DRAINAGE, LIPOMA, ABSCESS, PURULENT MATERIAL, BACTERIAL INFECTION, INFLAMMATORY EXUDATE, TENDERNESS, PANNUS, PAINFUL LUMP, MASS, ATTENUATION, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLANT OF MESH, HERNIA REPAIR WITH NEW MESH, REMOVAL OF ABSCESS CAVITY, DEBRIDEMENT OF FASCIA, REMOVAL OF LIPOMA, HERNIA REPAIR, AND MEDICATION.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Corneal Pannus; Discomfort; Fluid Discharge; Hernia; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11265295 ↗
• InjuryJan 6, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 11124224 ↗
• InjuryDec 15, 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 ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH EXPLANT.

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

  MAUDE report 11013061 ↗
• InjuryDec 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, INFECTION, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TAKEDOWN OF FISTULA, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, EXTENDED HOSPITALIZATION, AND SMALL BOWEL RESECTION.

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

  MAUDE report 10971218 ↗
• InjuryDec 1, 2020Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 ADHESIONS IN ABDOMINAL WALL, ABDOMINAL PAIN, PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, FAILURE OF MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH INTERVENTION SURGERY, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Fistula; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10928072 ↗