FDA Adverse Event
Other
Summary report: N
ENTERPRISE 9000+LIFTING POLE/ADJ STRAP & HANDLE
MDR report key: 2104989
·
Received May 6, 2011
Report
- Report Number
- 3003984900-2011-00014
- Event Type
- Other
- Date Received
- May 6, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 8, 2011
- Manufacturer
- ARJOHUNTLEIGH
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED PENDING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
THE PT WAS PULLING DOWN ON THE LIFTING HANDLE TO REPOSITION HIMSELF IN BED, WHEN THE RETRACTABLE STRAP MECHANISM LET LOOSE UNEXPECTEDLY. THIS CAUSED THE STRAP TO FULLY EXTEND AND THE HANDLE TO HIT THE PT IN THE FACE. THE PT HAD BOTH HANDS ON THE HANDLE AND THE STRAP RELEASE BUTTON WAS NOT TOUCHED. THE PT SUFFERED A SHORT LASTING MINOR NOSEBLEED AND HAD NO VISIBLE FACIAL INJURY (LACERATION, ABRASION, CONTUSION, ETC).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE 9000+LIFTING POLE/ADJ STRAP & HANDLE | ACCESSORIES - LIFTING & EQUIPMENT HANDLE | FSA | ARJOHUNTLEIGH | ENT-ACC03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |