ULTRAPRO UML1 (UDI 10705031085862)Recalls & reported problems
Johnson & Johnson Medical GmbH · Ultrapro MONOCRYL?-PROLENE?-COMPOSITE Poliglecaprone 25/Polypropylene · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031085862), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. AFTER A PERIOD OF 2 YEARS WHEN THE CULTURE EXAMINATION WAS PERFORMED, CANDIDA AURIS FUNGUS WAS VERIFIED. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).
Patient problems: Unspecified Infection
MAUDE report 23058274 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.