Surgipro SPM-66-WRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521101388), received between Nov 20, 2017 and Dec 10, 2024 — classified as 27 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (15 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 20893891 ↗
• InjuryMay 30, 2023Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Integrity 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, DEFECTIVE MESH, SINUS TRACT, INFECTION, GRANULOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 17020788 ↗
• InjuryApr 7, 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 A UROGYNECOLOGICAL THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CONSTIPATION, BOWEL URGENCY, DIARRHEA, RECTAL BLEEDING, PAIN, ABDOMINAL CRAMPS, AFFECTED PSYCHOLOGICALLY, RECTOCELE, RECTAL INTUSSUSCEPTION, RECTAL PROLAPSE, BOWEL PROTRUDING AFTER EACH BOWEL MOVEMENT, OBSTRUCTIVE DEFECATION, WEAKNESS OF PELVIC FLOOR. POST-OPERATIVE PATIENT TREATMENT INCLUDED VIDEO PROCTOGRAM, USE OF LAXATIVES, RECURRENT RECTAL PROLAPSE SURGERY, EUA OF RECTUM, LAPAROSCOPIC RECTOPEXY, COLONOSCOPY, PELVIC FLOOR PHYSIOTHERAPY ORDERED.

  Patient problems: Abdominal Cramps; Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Prolapse; Unspecified Tissue Injury

  MAUDE report 16702992 ↗
• InjuryFeb 15, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, SCARRING, DISFIGUREMENT, LOSS OF ENJOYMENT OF LIFE, PERMANENT PHYSICAL DISABILITY, LOSS OF PHYSICAL, MENTAL & EMOTIONAL HEALTH, DEFECTIVE DEVICE, SCAR TISSUE, HERNIA RECURRENCE, INFLAMED GRANULATION TISSUE, ABDOMINAL WOUND, STAPHYLOCOCCUS AUREUS; CORYNEFORM BACTERIA , ABNORMAL ERYTHROCYTE SEDIMENTATION RATE, FIBROADIPOSE TISSUE, FIBROSIS, FOREIGN BODY REACTION, CHRONIC INFLAMMATION, WOUND DEHISCENCE, ABSCESS, WOUND DRAINAGE, RED OPEN WOUND, DRAINING PUS AND SEROSANGUINOUS FLUID, PYROGENIC GRANULOMA OF ABDOMINAL WALL, INFECTION, PURULENT DRAINAGE, DEHISCENCE, ERYTHEMA, NON-HEALING WOUND, WOUND TRACT, & SINUS TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, ANTIBIOTICS, ABSCESS INCISION AND DRAINAGE, REMOVAL OF INFECTED SUTURE, PARTIAL REMOVAL OF MESH, WOUND VAC, MULTIPLE MESH DEBRIDEMENT'S, & INCISION AND DRAINAGE OF LEFT SINUS TRACT.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Deformity/ Disfigurement; Emotional Changes; Erythema; Fibrosis; Fluid Discharge; Foreign Body Reaction; Granuloma; Hernia; Impaired Healing; Inflammation; Pain; Purulent Discharge; Pyogenic Infection; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16383252 ↗
• InjuryFeb 17, 2022Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, ADHESIONS, INFLAMMATION, AND MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chills; Decreased Appetite; Diaphoresis; Emotional Changes; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Pain; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13549432 ↗
• 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEVICE DEFECT, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 12178838 ↗
• InjuryJul 2, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; 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 THE IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ABSCESS, ADHESIONS, COMPONENT SEPARATION, SCARRING, MESH EROSION, BOWEL INFLAMMATION, AND PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF INFECTED MESH, AND REVISION SURGERY.

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

  MAUDE report 12112157 ↗
• InjuryJul 2, 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SCARRING, BULGING, PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Perforation; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12109168 ↗
• InjuryMay 17, 2021Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, SWISS CHEESE DEFECT, MENTAL PAIN, PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, DISCOMFORT, AND ADHESIONS TO SMALL INTESTINE. 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; Ascites; Chills; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 11837586 ↗
• InjuryMay 11, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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, INFECTION, ABSCESS, SEROMA, BOWEL OBSTRUCTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Emotional Changes; Erythema; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11807236 ↗
• InjuryMar 8, 2021Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 MESH BUNCHED, CONCRETE TYPE ADHESIONS, SCAR TISSUE, SCARRING, RECURRENCE, INABILITY TO IDENTIFY THE VASCULAR SUPPLY TO THE TESTICLE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF TESTICLE. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. THE REPORTER STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

  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 11435614 ↗
• InjuryMar 8, 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 ADHESIONS, PAIN, HERNIA RECURRENCE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Respiratory Insufficiency; Unspecified Tissue Injury; Vomiting

  MAUDE report 11435578 ↗
• InjuryOct 9, 2020Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 OVERLAY IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, RECURRENCE, INFLAMMATION, BACTERIAL PROLIFERATION, INFECTION, MESH DEGRADATION, MESH ENCASED IN BIOFILM, MESH DEFORMED, MESH NOT PROPERLY INCORPORATED, CHRONIC DRAINING ABSCESS, LARGE BULGE, ADHESIONS, AND RETRACTION OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, MESH PARTIALLY REMOVED, AND HERNIA REPAIR.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Bacterial Infection; Emotional Changes; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10657986 ↗
• InjurySep 29, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 10603414 ↗
• InjurySep 24, 2020Migration 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISCOMFORT, INFLAMMATION, MESH CONTRACTION, RECURRENCE, ADHESIONS, HEMATOMA, FATIGUE, FIBROUS TISSUE, DIFFICULTY URINATING, ERECTILE DYSFUNCTION, MESH WADDED UP AND WRAPPED UP, IBS, BLEEDING, AUTO IMMUNE COMPLICATIONS, AND CHRONIC GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL MESH REMOVAL, SHOULDICE REPAIR, MEDICATION, AND FULL REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Dysuria; Emotional Changes; Fatigue; Fibrosis; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Immunodeficiency; Inflammation; Injury; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 10583776 ↗
• InjurySep 23, 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, BOWEL LEAKAGE, PAIN, INFLAMMATION, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISABILITY, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ENTEROLYSIS OF SMALL BOWEL, MESH REVISION, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Discharge; Discomfort; Emotional Changes; Failure to Anastomose; Fluid Discharge; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10574528 ↗
• InjuryJul 17, 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, ADHESIONS, AND SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR AND REMOVAL OF MESH.

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

  MAUDE report 10289897 ↗
• InjuryJul 6, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10233464 ↗
• InjuryMay 14, 2020Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, FAILURE OF MESH, DRAINING SINUSES, WOUND INFECTION, SUPERFICIAL DEHISCENCE WITH GRANULATION TISSUE, MESH PROTRUDING, PURULENT MATERIAL, AND LACK OF INCORPORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF WOUND WITH DEBRIDEMENT, PATIENT ADMITTED POST-OPERATIVELY, IV ANTIBIOTIC THERAPY, AND REMOVAL OF MESH.

  Patient problems: Abscess; Bacterial Infection; Discharge; Emotional Changes; Failure of Implant; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10057346 ↗
• InjuryApr 17, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 RECURRENCE, MESH STRETCHED AND LOOSE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Injury

  MAUDE report 9974165 ↗
• InjuryDec 13, 2019Adverse 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. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER INLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE OF PARASTOMAL HERNIA (STRANGULATED), ADHESIONS AS WELL AS MESH ERODED, ABSCESS, AND SEVERE INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY AND BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Erosion; Hernia; Inflammation; Injury; Unspecified Infection

  MAUDE report 9465523 ↗
• InjuryNov 13, 2019Adverse 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 SUPRAUMBILICAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND ADMITTED TO HOSPITAL.

  Patient problems: Adhesion(s); Distress; Hernia; Injury

  MAUDE report 9314090 ↗
• InjurySep 30, 2019Adverse 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Injury; Unspecified Tissue Injury

  MAUDE report 9136932 ↗
• InjuryAug 27, 2019Adverse 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 MESH INFECTION, ABSCESS, PAIN AND FISTULAS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

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

  MAUDE report 8938217 ↗
• InjuryAug 5, 2019Mechanics 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 A RECURRENT UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEVERE PAIN, INFECTION, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, EXTREME WEIGHT LOSS, WORSENING ABDOMINAL PAIN AND SMALL POCKET OF PUS UNDER MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. THE PATIENT HAS ONGOING MEDICAL ISSUES INCLUDING THE NEED FOR FUTURE MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Diarrhea; Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Nausea; No Code Available; Nodule; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 8859588 ↗