FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 10764079
·
Received October 30, 2020
Report
- Report Number
- 1523658-2020-00008
- Event Type
- Malfunction
- Date Received
- October 30, 2020
- Report Date
- November 11, 2020
- Manufacturer
- BATTELLE MEMORIAL INSTITUTE
- Product Code
- QKY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
CORRECTION OF PRODUCT CODE FROM QLA TO QKY BASED ON FDA FEEDBACK.
Additional Manufacturer Narrative · 1
ALTHOUGH NO MALFUNCTION OR SERIOUS INJURY OF THE DECONTAMINATED RESPIRATOR HAS BEEN CONFIRMED, THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA. CCDS STAFF HAS BEEN IN CONTACT WITH HCP, EXPLAINING THE DECONTAMINATION PROCESS, THE CHEMICALS USED (SDSS), AND PROVIDED A LINK TO FAQS FOR HCPS AS WELL AS SUGGESTING AIRING OUT THE MASKS PRIOR TO USE. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION.
Description of Event or Problem · 1
USER REPORTED RASH, ITCHY, BURNING UNDER CHIN. THE MASK ASSOCIATED WITH THIS EVENT WAS DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1231140 | NA | RESPIRATOR, DECONTAMINATED | QKY | BATTELLE MEMORIAL INSTITUTE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |