FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 10801511
·
Received November 6, 2020
Report
- Report Number
- 1523658-2020-00183
- Event Type
- Malfunction
- Date Received
- November 6, 2020
- Report Date
- November 5, 2020
- Manufacturer
- BATTELLE MEMORIAL INSTITUTE
- Product Code
- QKY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. CCDS STAFF HAS BEEN IN CONTACT WITH HCP, EXPLAINING THE DECONTAMINATION PROCESS, THE CHEMICALS USED (SDSS), AND PROVIDED A LINK TO FAQS FOR HCPS. ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA.
Description of Event or Problem · 1
USER REPORTED FACE WAS RED AND ITCHING UNDER THE MASK. THE MASKS ASSOCIATED WITH THIS EVENT WERE DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264972 | NA | RESPIRATOR, DECONTAMINATED | QKY | BATTELLE MEMORIAL INSTITUTE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |