FDA Adverse Event
Malfunction
Summary report: N
TBL COMPONENT, 5TH WHEEL TABLE SEAT SECTION ON
MDR report key: 1621928
·
Received February 5, 2010
Report
- Report Number
- 2031963-2009-00056
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- October 2, 2007
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER COMMUNICATIONS
- Product Code
- FQO
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 7/1/2006 TO 7/1/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION #(B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE FQO.
Description of Event or Problem · 1
SHARP EDGES. IT WAS REPORTED THAT THE ACCESSORY CHANNELS HAVE VERY SHARP EDGES, SOME SHARPER THAN OTHERS. (CAN THIS CUT THE USER OR PATIENT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TBL COMPONENT, 5TH WHEEL TABLE SEAT SECTION ON | FQO | STRYKER COMMUNICATIONS | NA | 070524-30892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |