FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 10764028
·
Received October 30, 2020
Report
- Report Number
- 1523658-2020-00012
- Event Type
- Malfunction
- Date Received
- October 30, 2020
- Report Date
- November 11, 2020
- Manufacturer
- BATTELLE MEMORIAL INSTITUTE
- Product Code
- QKY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
CORRECTION OF PRODUCT CODE FROM QLA TO QKY BASED ON FDA FEEDBACK AND ADDED AWARE DATE (G3).
Additional Manufacturer Narrative · 1
CCDS STAFF AND HCP ARE IN DISCUSSION PROVIDING ADDITIONAL INFORMATION CONCERNING THE DECONTAMINATION PROCESS AS WELL AS FAQS ANSWERING CUSTOMER QUESTIONS CONCERNING MASK FIT. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION.
Description of Event or Problem · 1
USER REPORTED AFTER DECONTAMINATION STRAP BROKE ON FIRST ATTEMPT TO WEAR. 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 |
|---|---|---|---|---|---|---|---|
| 1229243 | NA | RESPIRATOR, DECONTAMINATED | QKY | BATTELLE MEMORIAL INSTITUTE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |