MalfunctionMSH
N95 46867 SMALL (REPROCESSED)
Received Aug 17, 2020 · Event occurred Aug 13, 2020
Report MW5096100 · MDR key 10419722
Device
Generic name
Respirator, Surgical
Manufacturer
BattelleProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
23 YR
- Itching Sensation
- Rash
- Reaction
- Itching Sensation
- Rash
- Reaction
Narrative
Description of Event or Problem
REPROCESSED MASK FROM BATTELLE- LEFT SIDE OF CHEEK BROKE OUT IN HIVES (ITCHING AND BUMPS) AFTER WEARING IT DURING THE AM; (B)(6).