Surgipro SMHP-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521176003), received between May 18, 2021 and Jan 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, PAIN, RECURRENCE, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, NEURECTOMY, HERNIA REPAIR WITH MESH.

  Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24192146 ↗
• InjuryMay 18, 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SMALL BOWEL OBSTRUCTION, MESH FOLDED/ROLLED/WADDED UP, ABSCESS, SCARRING, ADHESIONS, FISTULA, INFLAMMATION, OPEN DRAINING WOUND, PAIN, HEMATOMA, SEROMA, ABDOMINAL PUS SAC, NECROSIS, DRAINAGE, BLEEDING, AND PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION AND DRAINAGE, HERNIA REPAIR WITH NEW MESH, UMBILICUS AND SURROUNDING SKIN EXCISED, AND MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Ascites; Decreased Appetite; Fever; Fistula; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Ulcer; Unspecified Tissue Injury

  MAUDE report 11845959 ↗