FDA Adverse Event
Injury
Summary report: N
ISOFLEX 35X84X6 NYLON
MDR report key: 3017905
·
Received March 22, 2013
Report
- Report Number
- 0001831750-2013-02336
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 26, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FMW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER PROVIDED WITH A NEW MATTRESS
Description of Event or Problem · 1
IT WAS ALLEGED BY THE CUSTOMER THAT THEY HAVE SEEN PATIENTS DEVELOP PRESSURE ULCERS WHILE USING AN ISOFLEX MATTRESS. HOWEVER, AS THE CUSTOMER STATED THEY DID NOT RECORD ANY SERIAL NUMBERS FOR THE REPORTED PRESSURE ULCERS FOUND ON THEIR ISOFLEX MATTRESSES, IT IS NOT KNOWN IF THIS MATTRESS IS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO A PRESSURE ULCER DEVELOPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120722 | ISOFLEX 35X84X6 NYLON | COVER, MATTRESS (MEDICAL PURPOSES) | FMW | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |