Surgipro SPM-149Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521101333), received between Apr 20, 2018 and May 17, 2023 — classified as 1 death, 32 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (20 reports).

1 other recall cover devices cleared under the same FDA submission (K915526); they may or may not involve this specific model.

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 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ALLERGIC REACTION, BLEEDING, SCARRING, NERVE DAMAGE, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, SINUS TRACT, ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16949476 ↗
• InjuryMar 24, 2023Material 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 MESH CONTRACTION, DEFECTIVE MESH, INFECTION, SEROMA, RECURRENCE, ABSCESS, GRANULATION TISSUE, GRANULOMA, SCARRING, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, DEBRIDEMENT OF WOUND, DRAINAGE OF SEROMA, COMPLEX WOUND CLOSURE.

  Patient problems: Abscess; Emotional Changes; Granuloma; Hernia; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16611900 ↗
• InjuryJan 17, 2023Material 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, DEFECTIVE MESH, PAIN, MENTAL PAIN, DISABILITY, ABSCESS, ADHESIONS, INFECTION, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, GRANULOMA, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, SMALL BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Granuloma; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16186127 ↗
• InjuryAug 25, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESION, PAIN, DISCOMFORT, MESH FAILURE, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION, AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Emotional Changes; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15294680 ↗
• InjuryMar 10, 2022Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LACK OF INCORPORATION, INFECTION, ABSCESS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND REPAIR OF HERNIA.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Electrolyte Imbalance; Emotional Changes; Fibrosis; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Purulent Discharge; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13720364 ↗
• InjuryFeb 4, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL DIFFICULTIES, NAUSEA, VOMITING, PAIN, FAILURE OF MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, COMPONENT SEPARATION, SMALL BOWEL RESECTION, AND REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Emotional Changes; Fibrosis; Granuloma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Nodule; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Vomiting

  MAUDE report 13459675 ↗
• InjuryFeb 4, 2022Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, MESH DEGRADATION, INFLAMMATORY RESPONSE, MESH NOT INCORPORATED, CHRONIC DRAINING ABDOMINAL WOUND, PURULENT MATERIAL, SINUS TRACT, PAIN, RECURRENCE, DEFECTIVE MESH, FAILURE OF MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND MASS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, INVASIVE SURGERY, SINUS TRACT EXCISED WITH ELECTROCAUTERY, ABDOMINAL WOUND EVACUATED, HERNIA REPAIR WITH NEW MESH, AND DRAINAGE OF PURULENT MATERIAL.

  Patient problems: Abdominal Cramps; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Chills; Emotional Changes; Erythema; Fever; Fibrosis; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Nodule; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13459669 ↗
• InjuryAug 1, 2021Adverse 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 BILATERAL INGUINAL HERNIAS IN A LAPAROSCOPIC REPAIR AS WELL AS OPEN REPAIR OF RIGHT HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BLADDER EROSION, BLADDER OBSTRUCTION, URINARY RETENTION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF FOREIGN BODY/MESH, LYSIS OF ADHESIONS, ADMISSION TO HOSPITAL, CYSTOSCOPY, CYSTOSTOTOMY PLACEMENT, BLADDER REPAIRED WHERE MESH WAS ENTERING INTO BLADDER, AND LAVAGE OF ABDOMINAL CAVITY.

  Patient problems: Adhesion(s); Erosion; Obstruction/Occlusion; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 12257320 ↗
• DeathMay 28, 2021Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED CHRONIC INFECTED SEROMA, INFECTED MESH, GRAM-POSITIVE COCCI, DISCHARGE, UNINCORPORATED MESH, NON-HEALING ABDOMINAL WOUND, TENDERNESS, SWELLING, PAIN, RED TENDER AREA, PURULENT MATERIAL, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE/DEBRIDEMENT OF WOUND, BLAKE DRAIN, SEROMA CAVITY EXCISED, REMOVAL OF DRAIN, PARTIAL REMOVAL OF MESH, AND ASPIRATION OF SEROMA. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION OR ANY ASSOCIATION WITH THIS DEVICE.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Fluid Discharge; Impaired Healing; Insufficient Information; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11905009 ↗
• InjuryApr 1, 2021Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, SEROMA, DISPLACED MESH, SCAR TISSUE, INFLAMMATION, AND DRAINING SINUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF MESH, PRIMARY REPAIR OF HERNIA, ALL INFECTED INFLAMMATORY TISSUE APPEARED TO BE REMOVED, AND EXCISION OF SEROMA.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Depression; Distress; Emotional Changes; Fluid Discharge; Hernia; Inflammation; Internal Organ Perforation; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11606238 ↗
• InjuryFeb 1, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, PORTION OF MESH UNINCORPORATED AND FREE FLOATING, MESH MIGRATION, CHRONIC NON-HEALING FISTULOUS TRACT, INFLAMMATION, FIBROSIS, GRANULATION TISSUE, DRAINING OPEN SINUS, FOREIGN BODY, RECURRENCE, AND OPEN NON-HEALING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, EXCISION OF SKIN/SUBCUTANEOUS/MUSCLE TISSUE, LYSIS OF ADHESIONS, REMOVAL OF SUTURES, AND EXPLANT OF MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Fistula; Fluid Discharge; Foreign Body In Patient; Hernia; Impaired Healing; Inflammation; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11259235 ↗
• InjuryNov 18, 2020Migration 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, RECURRENCE, ADHESIONS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, ABDOMINAL WALL RECONSTRUCTION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Erythema; Fecal Incontinence; Fibrosis; Fluid Discharge; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 10860323 ↗
• InjuryNov 2, 2020Mechanics 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, MESH FAILURE, ABSCESS, INFECTION, PAIN, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Distress; Failure of Implant; Injury; Pain; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10774804 ↗
• InjuryJul 17, 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 DECREASED HEMOGLOBIN, CHELONAE CAUSING WOUND INFECTION, MESH COATED WITH PURULENT MATERIAL, INCREASED RESPIRATORY DISTRESS, DECREASED URINE OUTPUT, TENSE ABDOMEN, DILATED BOWEL AND ROUX LIMB, CLOT INRIGHT FLANK AND INTO THE PELVIS, THE TWO PIECES OF MESH WERE MORE TENSE, LARGE ABDOMINAL OPEN WOUND WITH CONTINUED DRAINAGE, EXPOSED MESH, WEAKNESS, WEIGHT LOSS, INFECTED MESH, PUNCTATE OPENING, OPEN LESION, LOOSENING OF MESH, AND EXTRUDING MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED RETURNED TO OR, NG TUBE PLACED TO EVACUATE EXCESS AIR AND FLUID FROM COLON, SMALL BOWEL AND STOMACH, STAPLES AND SUTURES REMOVED TO EXPOSE THE MESH BASE, MESH WAS CUT SIDE TO SIDE AND CLOSED AGAIN WITH SUTURE, PRESENTED TO ED, HOSPITALIZED FOR ONE MONTH, IV ANTIBIOTICS, PICC LINE, WOUND REPACKED, SCHEDULED DRESSING CHANGES, POTASSIUM REPLETION, AGGRESSIVE IRRIGATION OF THE WOUND, IV FLUIDS, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discharge; Distress; Dyspnea; Fluid Discharge; Impaired Healing; Injury; Muscle Weakness/Atrophy; No Code Available; Obstruction/Occlusion; Purulent Discharge; Respiratory Distress; Respiratory Insufficiency; Thrombosis; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Weakness; Weight Changes

  MAUDE report 10292281 ↗
• InjuryJul 17, 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 DECREASED HEMOGLOBIN, CHELONAE CAUSING WOUND INFECTION, MESH COATED WITH PURULENT MATERIAL, INCREASED RESPIRATORY DISTRESS, DECREASED URINE OUTPUT, TENSE ABDOMEN, DILATED BOWEL AND ROUX LIMB, CLOT INRIGHT FLANK AND INTO THE PELVIS, THE TWO PIECES OF MESH WERE MORE TENSE, LARGE ABDOMINAL OPEN WOUND WITH CONTINUED DRAINAGE, EXPOSED MESH, WEAKNESS, WEIGHT LOSS, INFECTED MESH, PUNCTATE OPENING, OPEN LESION, LOOSENING OF MESH, AND EXTRUDING MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED RETURNED TO OR, NG TUBE PLACED TO EVACUATE EXCESS AIR AND FLUID FROM COLON, SMALL BOWEL AND STOMACH, STAPLES AND SUTURES REMOVED TO EXPOSE THE MESH BASE, MESH WAS CUT SIDE TO SIDE AND CLOSED AGAIN WITH SUTURE, PRESENTED TO ED, HOSPITALIZED FOR ONE MONTH, IV ANTIBIOTICS, PICC LINE, WOUND REPACKED, SCHEDULED DRESSING CHANGES, POTASSIUM REPLETION, AGGRESSIVE IRRIGATION OF THE WOUND, IV FLUIDS, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discharge; Distress; Dyspnea; Fluid Discharge; Impaired Healing; Injury; Muscle Weakness/Atrophy; No Code Available; Obstruction/Occlusion; Purulent Discharge; Respiratory Distress; Respiratory Insufficiency; Thrombosis; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Weakness; Weight Changes

  MAUDE report 10292252 ↗
• InjuryJul 14, 2020Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, BOWEL PERFORATION, MESH DEFORMATION, MESH MIGRATION, INFLAMMATION, FIBROSIS, VASCULAR CONGESTION, ADHESIONS, PROXIMAL DILATATION, DISTAL COLLAPSE, AREAS WITH TORSION AND VOLVULUS, NECROSIS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, REMOVAL OF MESH, REMOVAL OF SUTURES, EXCISION OF NECROTIC AREAS, AND EXTENDED HOSPITALIZATION.

  Patient problems: Adhesion(s); Bowel Perforation; Emotional Changes; Fibrosis; Hernia; Inflammation; Injury; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10273252 ↗
• InjuryJul 14, 2020Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE OVERLAY IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, BOWEL PERFORATION, MESH DEFORMATION, MESH MIGRATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND EXTENDED HOSPITALIZATION.

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

  MAUDE report 10273059 ↗
• InjuryApr 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION FAILURE OF MESH, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH. CONCOMITANT DEVICE: UNKNOWN STRYKER LOCK TUBE SET.

  Patient problems: Failure of Implant; Injury; Seroma; Unspecified Infection

  MAUDE report 9965170 ↗
• InjuryJan 24, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, HEMATOMA, BLEEDING, INFECTIONS, ABDOMINAL WALL FLUID COLLECTION, ERYTHEMATOUS AREA, POCKETS/LOCULATIONS, ABSCESS, MSSA, DISTENTION, ABDOMINAL PAIN, SKIN IRRITATION, ITCHING, MESH NOT INCORPORATED, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF ABDOMINAL WALL FLUID COLLECTION, MESH REMOVAL, RECURRENCE REPAIR, DRAINAGE OF ABSCESS, ABSCESS CAVITY EXCISED, ADMISSION TO HOSPITAL, ANTIBIOTICS, PLACEMENT OF DRAINS, AND WOUND VAC.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Blood Loss; Decreased Appetite; Emotional Changes; Erythema; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Itching Sensation; No Code Available; Obstruction/Occlusion; Pain; Skin Inflammation/ Irritation; Skin Irritation; Staphylococcus Aureus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9627388 ↗
• InjuryJan 22, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SEROMA, OPEN DRAINING WOUND AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGERY TO REMOVE MESH.

  Patient problems: Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discharge; Discomfort; Emotional Changes; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 9617297 ↗
• InjurySep 11, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTION, OPEN WOUND, MESH HAD BUNCHED DOWN AND WITHDRAWN NEARLY 7 CM FROM WHERE IT HAD BEEN ANCHORED, PHLEGMON SURROUNDING MESH AND INTRAABDOMINAL FLUID, ABDOMINAL PAIN, FEVER, MURKY FLUID, LARGE PURULENT PHLEGMON, AND MESH HAD BUNCHED DOWN AROUND THE PHLEGMON AND WITHDRAWN FROM WHERE IT HAD BEEN PREVIOUSLY ANCHORED. POST-OPERATIVE PATIENT TREATMENT INCLUDED ASPIRATION OF SUBFASCIAL ABSCESS, WOUND LEFT OPEN WITH PACKING, COMPLEX OPEN ABDOMINAL WOUND CLOSURE, EXPLANTATION OF INFECTED MESH AS WELL AS INCISION AND DRAINAGE OF INTRAABDOMINAL FLUID CONSISTENT WITH ABSCESS.

  Patient problems: Abdominal Pain; Abscess; Ascites; Fever; Impaired Healing; Injury; No Code Available; Purulent Discharge; Unspecified Infection

  MAUDE report 8987470 ↗
• InjurySep 2, 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 AN INCISIONAL AND PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, PURULENT FLUID, FAT NECROSIS, OPENWOUND, INFECTION, ABSCESS, EXTENSIVE ADHESIONS, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, INCISION AND DRAINAGE WITH SHARP DEBRIDEMENT OF SKIN/SUBCUTANEOUS TISSUE/FASCIA, LYSIS OF ADHESIONS, TAKEDOWN OF FISTULA, RESECTION OF INFECTED MESH, SMALL BOWEL ANASTOMOSIS, AND REVISION SURGERY.

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

  MAUDE report 8954069 ↗
• InjurySep 2, 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 AN INCISIONAL AND PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED, DEFECTIVE DEVICE, MENTAL AND PHYSICAL PAIN, INJURY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, RECURRENCE, PURULENT FLUID, FAT NECROSIS, OPEN WOUND, INFECTION, ABSCESS, EXTENSIVE ADHESIONS, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, INCISION AND DRAINAGE WITH SHARP D EBRIDEMENT OF SKIN/SUBCUTANEOUS TISSUE/FASCIA, LYSIS OF ADHESIONS, TAKEDOWN OF FISTULA, RESECTION OF INFECTED MESH, SMALL BOWEL ANASTOMOSIS, AND REVISION SURGERY.

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

  MAUDE report 8954066 ↗
• InjuryAug 23, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, OPEN WOUND, PSEUDO GRANULOMA, INFECTION, CHRONIC NON-HEALING WOUND WITH A SMALL DRAINAGE TRACT FROM THE MIDLINE SCAR, PURULENT MATERIAL, INFECTED UNINCORPORATED MESH, PAIN AT A FIRM MASS IN UPPER LEFT ABDOMEN, MULTIPLE PSEUDO GRANULOMATA, SCAR TISSUE, CYCLICAL FEVERS, CHILLS, ERYTHEMA, BULGE, PURULENT DRAINING DEFECT IN RIGHT LOWER QUADRANT, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, DEBRIDEMENT OF CAVITY, REMOVAL OF SCAR TISSUE, WOUND EXPLORATION, IV ANTIBIOTICS, REPAIR OF HERNIA WITH MESH, EXCISION OF INFECTED MESH AND SUTURES, EXCISION OF DRAINING SINUS TRACT, EXCISION OF GRANULOMA, AND INCISION AND DRAINAGE OF WOUND INFECTION.

  Patient problems: Abdominal Distention; Chills; Discharge; Erythema; Fever; Fistula; Hernia; Impaired Healing; Injury; No Code Available; Pain; Purulent Discharge; Scar Tissue; Scarring; Unspecified Infection

  MAUDE report 8927115 ↗
• InjuryAug 18, 2019Degraded; 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 VENTRAL 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, SEVERE PAIN, ABSCESS, RECURRENCE, INFECTION, SEROMA, ABDOMINAL WALL CELLULITIS, MESH CURLED UP INTO A BALL, DRAINING SINUS TRACT, BROWN MURKY MATERIAL, SCAR TISSUE, AND NECROTIC FAT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION AND DRAINAGE OF ABSCESS, REMOVAL OF MESH, REPAIR OF HERNIA WITH COMPONENT SEPARATION PROCEDURE, EXTENSIVE ENTEROLYSIS, PANNICULECTOMY, INCISION AND DRAINAGE OF SEROMA, EXCISION OF CHRONIC SINUS TRACT, MEDICATION, HEMOVAC DRAIN PLACEMENT, COMPLEX ABDOMINAL WALL RECONSTRUCTION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Emotional Changes; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Necrosis; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8904444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K915526. One submission often covers many models, so check the product and lot details in each record.

• Z-1009-2011 · Dec 15, 2010 · Terminated
  AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength