FDA Adverse Event
Malfunction
Summary report: N
POSEY STAYSAFE BED
MDR report key: 2140709
·
Received June 15, 2011
Report
- Report Number
- 2020362-2011-00215
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Report Date
- May 13, 2011
- Manufacturer
- J. T. POSEY CO.
- Product Code
- FNL
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT SHOWS THAT THE PT PANEL SIDE B: WINDOW ZIPPER SLIDER BODY IS OPEN; THE CANOPY BED STRAPS ARE FRAYED AND TORE FROM THE FRAME. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE STRAPS THAT SECURE THE TENT TO THE BED FRAME HAVE TORN FROM THE CANOPY MATERIAL. THE ISSUE WAS DISCOVERED DURING SET-UP. THERE WAS NO PT CONTACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY STAYSAFE BED | FNL | J. T. POSEY CO. | 8050 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |