CARDINAL HEALTH SEN73FPTAARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488952598), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 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.

• InjuryNov 6, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT DURING A MAXILLO-FACIAL PROCEDURE, THE BLUE, NON-X-RAY, COTTON OR TOWELS PWTB04-STM FROM THE MAXILLO FACIAL PACK/ SEN73FPTAA WERE SHEDDING THREADS AND FUZZ ONTO THE INSTRUMENTS, PATIENT AND THE IMPLANT/BONE CEMENT. THE TOWELS WERE USED TO SURROUND THE PATIENT¿S FACE AND TO COVER THE BACK TABLE. THE PATIENT DEVELOPED A POST-OP INFECTION REQUIRING A TRIP BACK TO THE OR FOR IRRIGATION AND DEBRIDEMENT AND POST-OP ANTIBIOTICS. NO FURTHER DETAILS REGARDING THE INFECTION OR PROCEDURE WERE PROVIDED. NO PATIENT DEMOGRAPHICS OR EVENT DATE WERE PROVIDED AFTER MULTIPLE ATTEMPTS WERE MADE TO GATHER THE INFORMATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9287718 ↗