FDA Adverse Event
Injury
Summary report: N
ISOFLEX MEDSURG MATTRESS MODEL
MDR report key: 2158100
·
Received June 30, 2011
Report
- Report Number
- 1313850-2011-00157
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 2, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FOH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS BEEN UNRESPONSIVE TO MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFO ON THIS REPORTED EVENT. F/U WILL BE FILED AS NECESSARY BASED UPON INVESTIGATIONS RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT RECENTLY DEVELOPED AN UNSTAGEABLE PRESSURE ULCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX MEDSURG MATTRESS MODEL | MATTRESS | FOH | STRYKER CORP DBA GAYMAR | 2800100997 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |