FDA Adverse Event
Malfunction
Summary report: N
LATERAL TURN MATTRESS W/AP AND LAL, 45 DEG Z CELL 36 X 80 X 15 9153647230
MDR report key: 4934685
·
Received July 23, 2015
Report
- Report Number
- 1031452-2015-14999
- Event Type
- Malfunction
- Date Received
- July 23, 2015
- Report Date
- June 26, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
THE CONSUMER STATED THE TURN Q MATTRESS THAT SHE HAS, HAS A HOLE IN A BLADDER. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479912 | LATERAL TURN MATTRESS W/AP AND LAL, 45 DEG Z CELL 36 X 80 X 15 9153647230 | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | INVACARE FLORIDA OPERATIONS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |