Surgipro SPM-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10884521101364), received between Sep 19, 2017 and Jan 17, 2025 — classified as 1 death, 120 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (67 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Distress; Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 21185621 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 INFECTION, ABSCESS, PAIN, SEROMA, DYSURIA, DIFFICULTY STANDING WHILE URINATING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, RIGHT GROIN EXPLORATION, AND DRAINAGE OF RIGHT GROIN ABSCESS.

  Patient problems: Abscess; Ascites; Dysuria; Emotional Changes; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20698431 ↗
• InjurySep 12, 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 A INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SLIGHTLY ENLARGED LYMPH NODE, INFLAMMATORY NODE, LABS ABNORMAL FOR CRP, HERNIA RECURRENCE, INGUINAL PAIN, TESTICULAR SWELLING, LUMP, SCARRING, PAIN IMPACTED ACTIVITIES OF DAILY LIVING & SLEEP PATTERNS, NERVE ENTRAPMENT PAIN, HEADACHES, TESTICULAR DISCOMFORT, NUMBNESS, DIFFICULT TO COMPLETE TASKS AT WORK, CELLULITIS, TENDERNESS, POOR QUALITY SLEEP, NAUSEA, VOMITING, & ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, CT SCAN, ULTRASOUND, MEDICATION, NERVE BLOCK, IV ANTIBIOTICS, PAIN MEDICATION, & NERVE INFILTRATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Discomfort; Headache; Hernia; Inflammation; Nausea; Nodule; Numbness; Pain; Scar Tissue; Sleep Dysfunction; Swelling/ Edema; Swollen Lymph Nodes/Glands; Unspecified Tissue Injury; Vomiting

  MAUDE report 20207331 ↗
• DeathFeb 26, 2024Mechanics 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, INFECTION, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE REVISION SURGERIES, PARTIAL REMOVAL OF MESH, ANTIBIOTIC TREATMENT, WOUND VAC. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO RECURRENT HERNIA PROCEDURES.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18783950 ↗
• InjuryNov 10, 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, RECURRENCE, GRANULOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 18113142 ↗
• InjuryJul 26, 2023Migration 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH WADDED, DEFECTIVE MESH, MESH CONTRACTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, GRANULOMA, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 17397517 ↗
• InjuryJul 13, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, NERVE DAMAGE, DISFIGUREMENT, EMOTIONAL DISTRESS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH.

  Patient problems: Adhesion(s); Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 17317960 ↗
• InjuryJun 30, 2023Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH PROTRUSION, DEFECTIVE MESH, MESH CONTRACTION, GRANULOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, CYSTOTOMY.

  Patient problems: Abscess; Adhesion(s); Depression; Emotional Changes; Erosion; Fistula; Granuloma; Hemorrhage/Blood Loss/Bleeding; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17238504 ↗
• InjuryJun 29, 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 FEMROAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, RECURRENCE, ADHESIONS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 17227815 ↗
• InjuryJun 29, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 17227096 ↗
• InjuryNov 1, 2022Degraded; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NAUSEA, FEVER, CHILLS, LOSS OF APPETITE, DISCOMFORT, PAIN, INFLAMMATION, MASS, SCAR TISSUE, GRANULOMA, NECROTIC TISSUE, PURULENT FLUID, DRAINING SINUS TRACT, BACTERIAL PERFORATION, INFECTION, MESH DEGRADATION, BACTERIAL INFECTION, MESH DEFORMED, FREE FLOATING MESH, MESH WAS NOT PROPERLY INCORPORATED IN TISSUE, ABSCESS, DEFECTIVE DEVICE, MESH FAILURE, IMPAIRMENT, DISABILITY, MENTAL PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, RIGHT INGUINAL EXPLORATION AND DEBRIDEMENT.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Chills; Decreased Appetite; Discomfort; Emotional Changes; Fever; Fluid Discharge; Granuloma; Inflammation; Nausea; Necrosis; Nodule; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15710956 ↗
• 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 AN PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INTEGRATED WITH THE SMALL BOWEL, FIBROSIS, ADHESIONS, HERNIA RECURRENCE, PAIN, DEFECTIVE DEVICE, INFLAMMATION, SUFFERING, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MESH FAILURE, MENTAL ANGUISH, EMOTIONAL DISTRESS, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND BOWEL RESECTION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Fibrosis; Fluid Discharge; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 14458287 ↗
• InjuryApr 21, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, SCARRING, DISFIGUREMENT, MENTAL PAIN, PAIN, ADHESIONS, EROSION, WOUND DEHISCENCE, INFECTION, ABSCESS, MESH NOT INCORPORATED, RECURRENCE, PERMANENT PHYSICAL DEFORMITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF ABSCESS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 14168935 ↗
• InjuryApr 21, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, SCARRING, DISFIGUREMENT, MENTAL PAIN, PAIN, ADHESIONS, EROSION, WOUND DEHISCENCE, INFECTION, ABSCESS, MESH NOT INCORPORATED, RECURRENCE, PERMANENT PHYSICAL DEFORMITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF ABSCESS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 14168114 ↗
• InjuryApr 7, 2022Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, BACTERIAL PROLIFERATION, INFECTION, DEGRADATION OF MESH, MESH ENCASED IN BIOFILM, MESH DEFORMED, MESH NOT PROPERLY INCORPORATED, CHRONIC DRAINING ABSCESS, PAIN, NERVE ENCIRCLED IN SUTURE AND MESH, NEUROMA, NERVE DAMAGE, DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, ADDITIONAL SURGERY, NERVES DIVIDED, AND MESH PARTIALLY REMOVED.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Nerve Damage; Neuropathy; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14049047 ↗
• InjuryApr 6, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SIGNIFICANT LEFT INGUINAL PAIN AND LEFT EPIDIDYMAL PAIN, SWELLING, SCAR TISSUE, HARD MESH, INFLAMMATION, ENTANGLEMENT OF THE SPERMATIC CORD, CHRONIC FOREIGN BODY REACTION, INFECTION, MESH ENCASED, RECURRENCE, SCARRING, LACK OF ADEQUATE INGROWTH, NERVE DAMAGE, SPERMATIC CORD INJURY, FAILURE OF MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVE HIS VAS DEFERENS/EPIDIDYMIS AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Nerve Damage; Pain; Perforation; Scar Tissue; Seroma; Sleep Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 14029069 ↗
• 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, INFECTION, ABSCESS, ADHESIONS, AND LACK OF INCORPORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, REPAIR OF HERNIA, AND WOUND VAC.

  Patient problems: Abscess; Adhesion(s); Ascites; Emotional Changes; Fever; Fibrosis; Fistula; Foreign Body Reaction; Hematoma; Hernia; Impaired Healing; Inflammation; Memory Loss/Impairment; Muscle Weakness/Atrophy; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13720391 ↗
• InjuryFeb 18, 2022Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE AND DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH INTERVENTION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Emotional Changes; Hernia; Inflammation; Ischemia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13559244 ↗
• InjuryDec 27, 2021Migration 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 PRODUCT FAILED, INFECTION, CAPSULE OF MESH, HERNIA RECURRENCE, ABDOMINAL PAIN, MENTAL/PHYSICAL PAIN, INFLAMMATION, BOWEL NECROSIS, FISTULA, EXTENSIVE BOWEL ADHESIONS, BOWEL DESEROSALIZATION, BOWEL EROSION, ENTEROTOMY, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE ATTEMPTS AT MESH REMOVAL SURGERY, SPLEEN REMOVAL, TREATMENT FOR INFECTION, BOWEL RESECTION, AND REMOVAL MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Emotional Changes; Erosion; Fever; Fibrosis; Fistula; Foreign Body Reaction; Granuloma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Low Blood Pressure/ Hypotension; Nausea; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Tachycardia; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention; Vomiting

  MAUDE report 13087593 ↗
• InjuryDec 7, 2021Degraded; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SCARRING, INFLAMMATION, BACTERIAL INFECTION, MESH DEGRADATION, MESH DEFORMED, MESH NOT INCORPORATED, CHRONIC DRAINING ABSCESS, ADHESIONS, MESH ADVANCED INTO STOMACH (EROSION), INFECTION, DEFECTIVE MESH, MENTAL AND PHYSICAL PAIN, DISABILITY, IMPAIRMENT, RECURRENCE, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, INSERTION OF MOSS GASTROSTOMY TUBE, EGD WITH STENT INSERTION FUNDOPLICATION, ESOPHAGEAL REPAIR, LAPAROTOMY WITH REMOVAL OF ERODED MESH, REVISION SURGERY, REMOVAL OF PORTIONS OF MESH, IRRIGATION AND DRAINAGE, HERNIA REPAIR WITH MESH, AND PRIMARY HERNIA REPAIR WITH SUTURES.

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

  MAUDE report 12953299 ↗
• InjuryOct 26, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PHYSICAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, INFECTION, ABDOMINAL PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chest Pain; Emotional Changes; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Nausea; Nodule; Obstruction/Occlusion; Pain; Perforation; Peritonitis; Pneumoperitoneum; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12699053 ↗
• InjuryOct 18, 2021Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; 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 INFECTED MESH, PAIN, SEROMA WITH THICKENED WALL, DEFECTIVE MESH, PURULENT MATERIAL, FRAGMENTED MESH, SCAR TISSUE, SPERMATIC CORD DENSELY SCLEROTIC, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, JACKSON-PRATT DRAIN PLACEMENT, HERNIA REPAIR WITH SUTURES, RIGHT GROIN EXPLORATION, EXCISION OF CHRONIC RIGHT GROIN SEROMA, RECONSTRUCTION OF RIGHT INGUINAL FLOOR, AND WOUND IRRIGATION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Hyperresponsive to stimuli; Inflammation; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12647393 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A EPIGASTRIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND ICU.

  Patient problems: Abdominal Pain; Unspecified Tissue Injury

  MAUDE report 12448998 ↗
• InjurySep 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE ADHESIONS, HERNIA RECURRENCE, SWISS CHEESE DEFECT, PROBLEMS EATING/DIGESTION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND SEVERE PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY, AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 12431051 ↗
• InjuryAug 13, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, ABDOMINAL PAIN, GROIN PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury; Urinary Tract Infection; Vomiting

  MAUDE report 12321001 ↗

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