Surgipro SMHP-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521176010), received between Mar 26, 2021 and Dec 16, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 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, ABSCESS, ADHESIONS, PAIN, RECURRENCE, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REVISION SURGERY, MESH REVISION, REMOVAL OF MESH.

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

  MAUDE report 23819146 ↗
• InjuryJan 2, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, KIDNEY ISSUES, BOWEL ISSUES, NUMBNESS, FEELING OF SOMETHING LEAKING, FEELING OF MESH BALLING/OUT OF PLACE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Discomfort; Hernia; Numbness; Pain; Unspecified Gastrointestinal Problem; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 21063615 ↗
• InjurySep 2, 2021Loss of or Failure to Bond; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED GROIN PAIN, HERNIA RECURRENCE, MESH DETACHMENT, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY, AND REMOVAL OF MESH.

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

  MAUDE report 12417800 ↗
• InjurySep 2, 2021Loss of or Failure to Bond; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED GROIN PAIN, HERNIA RECURRENCE, MESH DETACHMENT, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY.

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

  MAUDE report 12417755 ↗
• InjuryApr 26, 2021Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A UMBILICAL AND LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE GROIN PAIN, MESH FAILURE, MESHOMA, MESH CONTRACTION, MESH FOLDING, INFLAMMATION, MIGRATION, FAILURE TO INCORPORATE, ADHESIONS, AND NERVE ENTRAPMENT CAUSING CHRONIC LEFT GROIN AND TESTICULAR PAIN, SWELLING IN THE SCROTUM, LEFT INGUINODYNIA SECONDARY TO MESHOMA WITHIN THE DIRECT SPACE, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MESH REMOVAL SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Erosion; Failure of Implant; Foreign Body Reaction; Inflammation; Neuralgia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11725458 ↗
• InjuryMar 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ILIOINGUINAL NERVE TRAPPED IN MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, REMOVAL OF MESH, AND EXTERNAL OBLIQUE DISSECTED OFF OLD MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Unspecified Tissue Injury

  MAUDE report 11575944 ↗