FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PRODUCT
MDR report key: 2861866
·
Received October 31, 2012
Report
- Report Number
- 1831750-2012-11356
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 3, 2012
- Report Date
- October 3, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A VISUAL AND FUNCTIONAL INSPECTION WAS ALLEGEDLY PERFORMED BY (B)(6). THE ALLEGED INSPECTION IDENTIFIED THAT THERE WERE SHARP EDGES EXPOSED ON THE SIDE RAIL, WHICH WAS LIKELY DUE TO BROKEN RIVETS. UNIT WAS NOT REVIEWED BY STRYKER PERSONNEL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL RIVETS WERE DAMAGED WITH EXPOSED SHARP EDGES. CUSTOMER WAS NOT ABLE TO SUPPLY MODEL OR SERIAL NUMBER INFORMATION FOR THIS EVENT. THE CUSTOMER COULD NOT DETERMINE WHETHER THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT | UNKNOWN | FPO | STRYKER MEDICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |