FDA Adverse Event
Injury
Summary report: N
MASK
MDR report key: 17870488
·
Received October 3, 2023
Report
- Report Number
- MW5146523
- Event Type
- Injury
- Date Received
- October 3, 2023
- Date of Event
- September 27, 2023
- Report Date
- September 29, 2023
- Manufacturer
- SAFESOURCE DIRECT
- Product Code
- FXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
BAD PRODUCTS CAUSING HIVES. PRODUCTS ARE JOKES OR COUNTERFEIT. BAD MATERIALS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2277956 | MASK | MASK, SURGICAL | FXX | SAFESOURCE DIRECT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |