FDA Adverse Event
Other
Summary report: N
HOYER LIFTER W/SLING
MDR report key: 1883399
·
Received September 16, 2010
Report
- Report Number
- 2182305-2010-00034
- Event Type
- Other
- Date Received
- September 16, 2010
- Report Date
- August 20, 2010
- Manufacturer
- APEX HEALTHCARE MFR INC
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L MODEL #, CATALOG #: NA25503.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR BY FACILITY, (B)(6), PER THE SCHOOL THEY WANT TO RETURN ALL SLINGS; THEY STATE THEY ARE CUTTING INTO PT'S SKIN [?] ON THIS STATEMENT. CLAIMS THEY REQUESTED TO HAVE THESE SLINGS FIXED YRS AGO. MANUFACTURED SEARCH THEIR DATA BASE TO VERIFY "OTHER" COMPLAINTS FROM THIS SCHOOL, FOUND IN 2006 ONE COMPLAINT CAME IN AS A CUSTOMER DISSATISFIED WITH THE PRODUCT; STATING THE SLING IRRITATED A PT'S SKIN. THIS IS THE ONLY OTHER NOTICED REC'D, SO FROM 2006 TO PRESENT, THEY HAVE BEEN USING AN REPLACING PRODUCT, NOW THEY WANT ALL RETURNED. (B)(4) TO GET SLINGS BACK FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOYER LIFTER W/SLING | PATIENT LIFTER W/SLING | FNG | APEX HEALTHCARE MFR INC | NA25502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |