FDA Adverse Event
Other
Summary report: N
HOYER PRESENCE AND SLING
MDR report key: 3177560
·
Received June 12, 2013
Report
- Report Number
- 3009402404-2013-00030
- Event Type
- Other
- Date Received
- June 12, 2013
- Date of Event
- May 31, 2013
- Report Date
- June 11, 2013
- Manufacturer
- APEX HEALTHCARE MFR INC
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
JOERNS SENDING THE REPORT TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY ((B)(6)), PER THE FACILITY THE RESIDENT WAS BEING LIFTED WITH A MEDIUM FULL BACK SLING WHEN THE RESIDENTS LEFT SHOULDER SLING STRAP CAME OFF THE CRADLE. THE RESIDENT WAS SAFELY LOWERED TO THE BED. THE RESIDENT HAS NO INJURIES. (B)(6) FROM JOERNS VISITED THE FACILITY ON (B)(6) 2013 TO EVALUATE THE LIFT AND SLING. BOTH ARE IN GOOD CONDITION AND CONTINUE TO BE USED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265998 | HOYER PRESENCE AND SLING | PT LIFTER AND SLING | FNG | APEX HEALTHCARE MFR INC | HOY-PRESENCE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |