Surgipro SMPL-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521101319), received between Sep 22, 2017 and Aug 20, 2026 — classified as 1 death, 20 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• DeathAug 20, 2026Migration 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 an inguinal hernia. It was reported that after implant, the patient experienced adhesions, mesh migration, mesh shrinkage, nerve damage, pain, emotional distress, recurrence, death. Post-operative patient treatment included revision surgery and hernia repair with new mesh. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

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

  MAUDE report 50356523 ↗
• InjuryFeb 16, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED LIPOMA, PAIN, SUFFERING, SCARRING, DISCOMFORT, SEXUAL DYSFUNCTION, EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Discomfort; Distress; Hernia; Nodule; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 24348623 ↗
• InjuryAug 21, 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 PAIN, INFECTION, ADHESIONS, ABSCESS, AND ENLARGED TESTICLE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROSCOPY AND REMOVAL OF INFECTED MESH.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Inflammation; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20009719 ↗
• InjuryApr 30, 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 AN INGUINAL HERNIA WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS.

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

  MAUDE report 19216320 ↗
• MalfunctionOct 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF MESH APPLICATION, THE PLUG PORTION OF THE MESH BEGAN TO FALL APART UPON IMPLANTING THE DEVICE INTO THE PATIENT. THE SURGEON REMOVED THE PLUG AND OPENED A NEW DEVICE. HOWEVER, THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, THE SURGEON USED A NEW MESH AND SUTURE TO FIXATE THE NEW MESH INTO THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958863 ↗
• MalfunctionOct 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, AT THE TIME OF MESH APPLICATION, THE PLUG PORTION OF THE MESH BEGAN TO FALL APART UPON IMPLANTING THE DEVICE INTO THE PATIENT. THE SURGEON REMOVED THE PLUG AND OPENED A NEW DEVICE. HOWEVER, THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, THE SURGEON USED A NEW MESH AND SUTURE TO FIXATE THE NEW MESH INTO THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958600 ↗
• InjuryJul 13, 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, ADHESIONS, GRANULOMA, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17317706 ↗
• InjuryApr 19, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILED, RECURRENCE, PAIN, DEFECTIVE DEVICE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Numbness; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16773490 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE TO TWO MONTHS AFTER AN OPEN HERNIA RING FILLING SURGERY IN THE GROIN AREA, THE WOUND WAS INFECTED. THE PATIENT HAD TO RETURN TO THE HOSPITAL TO DE-INFLAME AND CLEAN THE WOUND. IT WAS ALSO NOTED THAT THE PATIENT HAD ONE WEEK OF EXTENDED HOSPITALIZATION. AT PRESENT, THE PATIENT RETURNED TO THE OUTPATIENT DEPARTMENT OF THE HOSPITAL FOR DRESSING CHANGE AND ANTI-INFLAMMATORY TREATMENT, AND THE CONDITION WAS MAINLY OBSERVED.

  Patient problems: Unspecified Infection

  MAUDE report 15104613 ↗
• InjuryMar 21, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, ADHESIONS AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.

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

  MAUDE report 13844089 ↗
• InjuryJan 28, 2022Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, LOSS OF ENJOYMENT OF LIFE, INABILITY TO PARTICIPATE IN PREVIOUS ACTIVITIES, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, REHABILITATION, AND REST.

  Patient problems: Emotional Changes; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Vasoconstriction

  MAUDE report 13385922 ↗
• MalfunctionNov 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA PROCEDURE, THE DEVICE HAS A THREE CM DEFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764394 ↗
• 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 MESH INFECTION, INFLAMMATORY REACTION TO MESH, ABSCESS, DRAINING WOUND, FISTULOUS TRACT EXTENDING TO MESH, DEFECTIVE MESH, FAILURE OF MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING, AND GRANULOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC PLACEMENT, REMOVAL OF MESH, AND REVISION SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Discomfort; Emotional Changes; Fistula; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12318382 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, LOSS OF ENJOYMENT OF LIFE, LOSS OF FLEXIBILITY IN LEFT GROIN/PELVIS, AND LIMITED MOBILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY AND ROBOTIC LEFT INGUINAL MESH PLUG REMOVAL WITH SUTURE REMOVALS.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 11386427 ↗
• InjuryDec 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 RIGHT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, RECURRENCE, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11082881 ↗
• InjuryDec 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 RIGHT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, RECURRENCE, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

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

  MAUDE report 11079716 ↗
• InjurySep 11, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10524783 ↗
• InjuryApr 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Nausea; Pain; Unspecified Tissue Injury

  MAUDE report 9974147 ↗
• InjuryApr 8, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE OVERLAY IMPLANT, THE PATIENT EXPERIENCED SCARRING, PERITONEAL INJURY, ADHESIONS, RECURRENCE, NAUSEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, BURNING SENSATIONS, AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH. NOTE THAT PLUG WAS UNABLE TO BE REMOVED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Chills; Decreased Appetite; Discomfort; Emotional Changes; Hernia; Inflammation; Injury; Nausea; No Code Available; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 9939488 ↗
• InjuryDec 9, 2019Migration 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER ONLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, LARGE LYMPH NODE, CHRONIC INFLAMMATORY LYMPH NODE, MESH MIGRATION, MESH BALLED UP IN RIGHT INGUINAL AREA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, REPAIR OF HERNIA WITH BARD FLAT MESH.

  Patient problems: Hernia; Inflammation; Injury; Swollen Lymph Nodes

  MAUDE report 9436836 ↗
• InjurySep 11, 2019Loss of or Failure to Bond; Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Material Erosion; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEROMA, MESH EROSION, MESH HAD PULLED AWAY FROM THE CONJOINT TENDON AND WAS BALLED UP IN THE MIDDLE OF INGUINAL CANAL, FLUID COLLECTION IN THE RIGHT GROIN, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED SEROMA SUCTION AND IRRIGATION AS WELL AS REMOVAL OF OLD MESH AND PLACEMENT OF NEW MESH.

  Patient problems: Ascites; Erosion; Hernia; Injury; Scarring; Seroma

  MAUDE report 8987409 ↗
• InjurySep 11, 2019Loss of or Failure to Bond; Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Material Erosion; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEROMA, MESH EROSION, MESH HAD PULLED AWAY FROM THE CONJOINT TENDON AND WAS BALLED UP IN THE MIDDLE OF INGUINAL CANAL, FLUID COLLECTION IN THE RIGHT GROIN, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED SEROMA SUCTION AND IRRIGATION AS WELL AS REMOVAL OF OLD MESH AND PLACEMENT OF NEW MESH.

  Patient problems: Ascites; Erosion; Hernia; Injury; Scarring; Seroma

  MAUDE report 8987404 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 DAYS AFTER RIGHT INGUINAL HERNIA FILLED WITH SACRAL HEMORRHOIDS AND REQUIRED SURGERY, THE PATIENT'S TEMPERATURE BECAME 39.1 DEGREES. ANTIPYRETIC SUPPLEMENT FLUID THERAPY WAS GIVEN.

  Patient problems: Fever; No Code Available

  MAUDE report 8976559 ↗
• MalfunctionApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE UNITS WERE SUSPECTED TO HAVE ADVERSE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7464390 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED POST-OPERATIVELY FOLLOWING AN OPEN INGUINAL HERNIA REPAIR. THE DEVICE HAD A DEFECT APPROXIMATELY 3-5CM AFTER THE INCISION. THERE WAS WOUND EXUDATE WHICH WAS INFECTED AND REQUIRED DRESSING FOR MORE THAN ONE MONTH. THE PATIENT STATUS IS ALIVE, WITH INJURY.

  Patient problems: Injury; No Code Available

  MAUDE report 7162744 ↗