FDA Adverse Event
Injury
Summary report: N
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
MDR report key: 17528887
·
Received August 12, 2023
Report
- Report Number
- MW5135816
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- February 4, 2020
- Manufacturer
- DRIVE
- Product Code
- FNM
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PER CUSTOMER STATES SHE HAS AN OVERLAY MANRESS FROM DOVE THAT IS HARD AND 1S CAUSMG BED SORES NO SERIAL NUMBER AVAILABLE AND NO ADDITIONAL INFORMATION PROVIDED 232451. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2217295 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | DRIVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |