PDO Max Threads PM19100L-FE-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850018324304), received between Jul 27, 2022 and Jul 27, 2022 — 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE THE PATIENT RECEIVED LEVO 19X100MM BARBED THREADS AND SMUTH S 30GX38MM SMOOTH THREADS. THE PATIENT NOTIFIED THE PROVIDER ON 7/11/22 THAT SHE HAD SOME SWELLING, SORENESS AND SOME DISCHARGE AFTER THE PROCEDURE. THE PROVIDER ALSO INJECTED PRP AT THE SAME TIME AS THREADS. PATIENT'S CONDITION WORSENED NEEDING HOSPITALIZATION. INFECTION PROGRESSED TO NECROTIZING FASCITIS AND REQUIRED 4-DAY HOSPITALIZATION STAY. THE MEDICAL DIRECTOR CALLED AND SPOKE WITH THE TREATING PHYSICIAN AND REVIEWED TREATMENT PLAN AND HOSPITALIZATION RECORDS. IT IS NOT BELIEVED THAT INFECTION WAS CAUSED BY THE THREADS THEMSELVES BUT THE PATIENT'S UNDERLYING MEDICAL HISTORY CONTRIBUTING TO THE POOR OUTCOME. THE PATIENT HAS SEVERAL MEDICAL CONDITIONS THAT ARE CONTRAINDICATIONS OUTLINED IN THE PROTOCOLS. THE PROTOCOLS WERE REVIEWED BY THE MEDICAL DIRECTOR WITH THE TREATING PHYSICIAN, AND THEY WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 15113919 ↗