Surgipro SPMM-149Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521101401), received between Dec 22, 2017 and May 19, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse 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 EMOTIONAL DISTRESS, PAIN, SUFFERING OPEN WOUND, ENTEROCOCCUS AND MRSA SEPSIS, & WOUND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, PARTIAL MESH REMOVAL, MESH REMOVAL, & WOUND CARE.

  Patient problems: Bacterial Infection; Distress; Impaired Healing; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25222041 ↗
• InjuryAug 22, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 22874931 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVIEW OF MEDICAL RECORDS RECEIVED FROM THE PATIENT'S ATTORNEY, ISSUES WERE IDENTIFIED AFTER THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS FOUND THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SEROMA FORMATION, PAIN, SWELLING, NAUSEA, DIARRHEA, ADHESIONS, UNUSUAL SENSATIONS, FLUID COLLECTIONS, DISCOMFORT, MUSCLE LAXITY, NERVE IRRITATION, ACHING, STABBING PAIN, SCARRING, WEAKNESS OF LATERAL ASPECT OF WOUND, MUSCULAR WEAKNESS, NERVE DAMAGE, INFLAMMATION, ABSCESS, CELLULITIS, SEPSIS, PURULENT FLUID, NECROTIC TISSUE, PAIN WITH BENDING FORWARD, ABDOMINAL PAIN, LOW MOOD, LOSS OF DOMAIN, POOR MUSCLE QUALITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, ULTRASOUND, MULTIPLE HOSPITALIZATIONS, FLUIDS, ANALGESIA, MESH REVISION, REPAIR OF HERNIA WITH SUTURES, USE OF DRAIN, ADHESIONS DIVIDED, GABAPENTIN, PAIN MEDICATION, SCAR SITE INJECTIONS, PARACETAMOL, ANTI-INFLAMMATORIES, PRIMARY HERNIA REPAIR, IV ANTIBIOTICS, INCISION DRAINAGE OF ABSCESS, NECROTIC TISSUE EXCISED, DELOCULATION, CURETTAGE, WOUND PACKING, WOUND CARE, HERNIA REPAIR WITH MESH, USE OF TRUSS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Diarrhea; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Nerve Damage; Pain; Purulent Discharge; Scar Tissue; Sepsis; Seroma; Swelling/ Edema; Unspecified Nervous System Problem; Unspecified Tissue Injury

  MAUDE report 20761294 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVIEW OF MEDICAL RECORDS RECEIVED FROM THE PATIENT'S ATTORNEY, ISSUES WERE IDENTIFIED AFTER THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS FOUND THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SEROMA FORMATION, PAIN, SWELLING, NAUSEA, DIARRHEA, ADHESIONS, UNUSUAL SENSATIONS, FLUID COLLECTIONS, DISCOMFORT, MUSCLE LAXITY, NERVE IRRITATION, ACHING, STABBING PAIN, SCARRING, WEAKNESS OF LATERAL ASPECT OF WOUND, MUSCULAR WEAKNESS, NERVE DAMAGE, INFLAMMATION, ABSCESS, CELLULITIS, SEPSIS, PURULENT FLUID, NECROTIC TISSUE, PAIN WITH BENDING FORWARD, ABDOMINAL PAIN, LOW MOOD, LOSS OF DOMAIN, & POOR MUSCLE QUALITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, ULTRASOUND, MULTIPLE HOSPITALIZATIONS, FLUIDS, ANALGESIA, MESH REVISION, REPAIR OF HERNIA WITH SUTURES, USE OF DRAIN, ADHESIONS DIVIDED, GABAPENTIN, PAIN MEDICATION, SCAR SITE INJECTIONS, PARACETAMOL, ANTI-INFLAMMATORIES, PRIMARY HERNIA REPAIR, IV ANTIBIOTICS, INCISION & DRAINAGE OF ABSCESS, NECROTIC TISSUE EXCISED, DELOCULATION, CURETTAGE, WOUND PACKING, WOUND CARE, HERNIA REPAIR WITH MESH, & USE OF TRUSS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Diarrhea; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Nerve Damage; Pain; Purulent Discharge; Scar Tissue; Sepsis; Seroma; Swelling/ Edema; Unspecified Nervous System Problem; Unspecified Tissue Injury

  MAUDE report 20760820 ↗
• InjuryMay 19, 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 THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, FISTULA, INFECTION, AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, DEBRIDEMENT, AND MESH REMOVAL.

  Patient problems: Abscess; Fistula; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11852079 ↗
• 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED A REVISION SURGERY, AND A HERNIA REPAIR SURGERY WITH MESH.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 11787634 ↗
• InjuryJan 22, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, DISCOMFORT, INFLAMMATION, INFECTION, GRANULATION TISSUE, AND MESH DETACHMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Discomfort; Emotional Changes; Fluid Discharge; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11214414 ↗
• InjuryDec 5, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS, MRSA, DILATED BOWEL, SCARRING, EDEMATOUS/INFLAMMATORY TISSUE, TENDER, SEROMA, WINKLED MESH, ISCHEMIA, FISTULA, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION TO HOSPITAL, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, REMOVAL OF MESH, VACUUM CLOSURE OF ABDOMEN, ENTEROTOMY REPAIR, REMOVAL OF WOUND VAC, DEBRIDEMENT OF SKIN/SUBCUTANEOUS TISSUE, SECONDARY CLOSURE OF WOUND, RIM OF SKIN INCISED, BOWEL RESECTION, CT SCAN.

  Patient problems: Adhesion(s); Bacterial Infection; Discomfort; Distress; Fistula; Hernia; Inflammation; Ischemia; Obstruction/Occlusion; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10951613 ↗
• InjuryNov 18, 2020Mechanics 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY, REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abscess; Constipation; Diarrhea; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 10860955 ↗
• InjuryNov 18, 2020Mechanics 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SINUS TRACT, NECROSIS, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH AND MESH REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hematoma; Hernia; Impaired Healing; Inflammation; Nausea; Necrosis; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Vomiting

  MAUDE report 10860156 ↗
• InjuryAug 13, 2020Adverse 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VAGINAL PROLAPSE AND URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED VAGINAL DISCHARGE, E COLI, KLEBSIELLA, PNEUMONIA, TWO TYPES OF ANAEROBE, HEMATOMA, LOW HEMOGLOBIN, TENDERNESS, BURNING SENSATION, FISTULA, AND EXPOSURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED VAGINAL SKIN VAULT TRIMMING, OPERATIVE CYSTOSCOPY, ADMISSION TO HOSPITAL, MEDICATION, AND EXCISION OF SMALL AREA OF EXPOSED MESH.

  Patient problems: Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Burning Sensation; Discomfort; Erosion; Fistula; Hematoma; Injury; Unspecified Tissue Injury

  MAUDE report 10405295 ↗
• InjuryFeb 6, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, ADHESIONS TO MESH, MESH MIGRATED AND CAME FREE FROM ABDOMINAL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Anemia; Anxiety; Depression; Emotional Changes; Fatigue; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 9679268 ↗
• InjuryJan 28, 2020Mechanics 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 RETRO RECTUS HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Decreased Appetite; Depression; Emotional Changes; Hematoma; Hernia; Inflammation; Injury; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Sleep Dysfunction; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Weight Changes

  MAUDE report 9639069 ↗
• InjuryOct 7, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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 ONLAY IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, HERNIA RECURRENCE, MESH EROSION, INCARCERATION, NECROSIS, INFECTION, FOREIGN BODY REACTION, ADHESIONS, ACUTE ABDOMINAL PAIN, AND LARGE AMOUNT OF MURKY FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Erosion; Foreign Body Reaction; Hernia; Injury; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9164358 ↗
• InjuryJul 23, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATORY REACTION, ADHESIONS, SEROMA, LARGE ABDOMINAL MASS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF INCISIONAL HERNIA, PLACEMENT OF MESH, EXCISION OF MASS, AND INTERMEDIATE WOUND CLOSURE.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; No Code Available; Nodule; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 8815670 ↗
• InjuryNov 6, 2018Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC HYSTEROPEXY/ Y/ MESH PLACEMENT FOR PELVIC ORGAN PROLAPSE, THE MESH ERODED. THE PATIENT ATTENDED WITH PAIN AND RECURRENCE OF PELVIC ORGAN PROLAPSE. THE PATIENT REQUESTED TO REMOVE THE MESH. LAPAROSCOPIC ASSISTED REMOVAL OF MESH AND SUBSEQUENT VAGINAL HYSTERECTOMY AND ANTERIOR COLPORRHAPHY WAS DONE TO RESOLVE THE ISSUE. AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE RESULTED FROM THIS PROBLEM. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Pain; Prolapse; Tissue Damage

  MAUDE report 8042240 ↗
• InjuryJun 27, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE REASON FOR MESH IMPLANTATION WAS STAGE II UTEROVAGINAL PROLAPSE AND DYSPAREUNIA. THE PROCEDURE PERFORMED WAS TOTAL ABDOMINAL HYSTERECTOMY AND ABDOMINAL SACROCOLPOPEXY. COMPLICATIONS POST SURGIPRO IMPLANT WAS VAGINAL CUFF MESH EROSION.

  Patient problems: Erosion; Injury

  MAUDE report 7642838 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A SACROCOLPOPEXY PROCEDURE LAST 2015, THE DEVICE WAS USED FOR PELVIC ORGAN PROLAPSE, HOWEVER VAGINAL MESH EXPOSURE WAS NOTED EIGHTEEN (18) MONTHS LATER. PATIENT UNDERWENT FURTHER SURGERY AND HAD A PARTIAL EXCISION OF THE MESH 2017 AND RECOVERING OF THE MESH EXPOSURE.

  Patient problems: No Code Available

  MAUDE report 7141755 ↗

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