FDA Adverse Event
Other
Summary report: N
MATTRESS COVER FOR MEDICAL PURPOSES
MDR report key: 2392362
·
Received December 16, 2011
Report
- Report Number
- 3008581949-2011-00001
- Event Type
- Other
- Date Received
- December 16, 2011
- Date of Event
- October 1, 2011
- Report Date
- December 16, 2011
- Manufacturer
- HICKORY SPRINGS MFG. CO.
- Product Code
- KME
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REPORTED, 5185B, IS A GENERAL PURPOSE MEDICAL MATTRESS AND IS NOT A REGISTERED MEDICAL DEVICE. THE PT'S WEIGHT EXCEEDS THE DISTRIBUTORS RECOMMENDED WEIGHT LIMIT OF 250 LB.
Description of Event or Problem · 1
DEALER ALLEGES THAT THE MATTRESS IS BREAKING DOWN. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATTRESS COVER FOR MEDICAL PURPOSES | 880.6190 | KME | HICKORY SPRINGS MFG. CO. | 5185B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |