FDA Adverse Event
Malfunction
Summary report: N
POSEY BED
MDR report key: 3856487
·
Received April 18, 2014
Report
- Report Number
- 2020362-2014-00156
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Report Date
- February 27, 2014
- Manufacturer
- J. T. POSEY COMPANY
- Product Code
- OYS
- PMA / PMN Number
- K113355
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE PATIENT ACCESS PANEL SIDE B ZIPPER SLIDER BODY IS OPEN. WINDOW SIDE A, INSERT PIN IS RIPPED FROM ZIPPER TAPE. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE PULL TAB HAS BROKEN OFF THE ZIPPER LOCATED AT THE RIGHT SIDE PANEL. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN. NO PATIENT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238820 | POSEY BED | OYS | J. T. POSEY COMPANY | 8060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |