PDS PDPB741DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031218888), received between Jul 24, 2020 and Apr 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE FASCIA. POST-OP, NON-INFLAMMATORY PUS-LIKE SYMPTOM OCCURRED. THE PATIENT HAD INFLAMMATION ON THE WOUND. THE SUTURE WAS REMOVED, AND THE WOUND WAS WASHED AND RE-SUTURED WITH NYLON. THE PATIENT RECOVERED. THE PRODUCT USED WAS UNKNOWN, AND IT WAS ALSO UNCLEAR WHETHER THE COMPANY¿S PRODUCT WAS USED, SO THE PRODUCT CODE OF THE DELIVERED PRODUCT WAS ENTERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Purulent Discharge

  MAUDE report 14166038 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE PART AS SOON AS THE NEEDLE WAS HELD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320326 ↗