ULTRAPRO ADVANCED UPA3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031236981), received between Oct 15, 2019 and Jan 14, 2025 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REDUCTION OF INCARCERATED CECUM WITH PARTIAL OMENTECTOMY AND COMPLETE RESECTION OF INDIRECT HERNIA SAC WITH A LARGE MESH, TENSION-FREE REPAIR OF RIGHT DIRECT AND INDIRECT INGUINAL HERNIA ON (B)(6) 2022. IN EARLY 2024, THE PATIENT HAS STARTED EXPERIENCING THE FOLLOWING ISSUES: BOWEL ISSUES, CHRONIC PAIN, FEVER, GASTROINTESTINAL ISSUES, HERNIA RECURRENCE, INFECTION, INFLAMMATION, NAUSEA AND RECURRENCE. ADDITIONAL INFORMATION WAS REQUESTED,

  Patient problems: Discomfort; Fever; Hernia; Inflammation; Nausea; Neuralgia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21152953 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 21088412 ↗
• InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT VENTRAL INCISIONAL REPAIR ON (B)(6) 2019 WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION DURING WHICH THE SURGEON NOTED INTRAABDOMINAL ADHESIONS SECONDARY TO DUAL MESH. THE MESH WAS TUCKED TO THE ABDOMEN WALL ALONG WITH A SMALL BOWEL TO THE MESH REQUIRING RESECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2020. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20647027 ↗
• InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY AND RECURRENT VENTRAL INCISIONAL REPAIR ON (B)(6) 2019 WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION DURING WHICH THE SURGEON NOTED INTRAABDOMINAL ADHESIONS SECONDARY TO DUAL MESH. THE MESH WAS TUCKED TO THE ABDOMEN WALL ALONG WITH A SMALL BOWEL TO THE MESH REQUIRING RESECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2020. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20646913 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED ¿DENSE BOWEL ADHESIONS. THE TRANSVERSE COLON WAS DENSELY ADHERED TO THE ANTERIOR ABDOMINAL WALL. THERE WERE CONSIDERABLE ADHESIONS OF TRANSVERSE COLON, OMENTUM AND SMALL BOWEL TO THE ABDOMINAL WALL, IN THE MID-ABDOMEN.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND CHRONIC ABDOMINAL PAIN. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2010. OTHER IMPLANTED PRODUCT IS CAPTURED UNDER A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Pain

  MAUDE report 9191336 ↗