inforMED
InjuryMSH

MOLDEX

Received Sep 2, 2020 · Event occurred Sep 1, 2020

Report MW5096408 · MDR key 10487720

Device

Generic name

Respirator, Surgical

Catalog number

1512

Product problems

  • Product Quality Problem

Patient

63 YR

  • Dyspnea
  • Dyspnea

Narrative

Description of Event or Problem

CRNA USING REPROCESSED MASK FROM (B)(6). BECAME SHORT OF BREATH AND UNABLE TO BREATHE WHEN WEARING REPROCESSED MASK. NEW MASK GIVEN, NO FURTHER PROBLEMS REPORTED. FDA SAFETY REPORT ID# (B)(4).