FDA Adverse Event
Death
Summary report: N
MEDICHOICE ULTIMATE OFF LOADING
MDR report key: 4184189
·
Received August 7, 2014
Report
- Report Number
- 2431497-2014-00001
- Event Type
- Death
- Date Received
- August 7, 2014
- Date of Event
- May 7, 2014
- Report Date
- August 6, 2014
- Manufacturer
- SKIL-CARE CORP.
- Product Code
- FMP
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NOTE: "CAUTION" SECTION ON SECOND PAGE OF INSTRUCTION SHEET PACKAGED IN EVERY ULTIMATE OFF-LOADING HEEL BOOT - COMMENT #2 "DO NOT ALLOW PATIENT TO WALK OR STAND ON THE FLOOR WHILE WEARING THE BOOT".
Description of Event or Problem · 1
MALE PT AT A SKILLED NURSING HOME (NOT IDENTIFIED) FOUND ON FLOOR WITH A HEAD LACERATION AND CONFUSION. WAS FOUND TO HAVE SUSTAINED EXTENSIVE INTRACRANIAL HEMORRHAGE DURING FALL. AS NOTED IN VOLUNTARY REPORT NO. (B)(6) (ATTACHED): RESIDENT WAS FOUND ON FLOOR WITH HEAD LACERATION AND CONFUSION CAUSED BY A FALL. RESIDENT WAS FOUND WEARING MEDICHOICE ULTIMATE OFF-LOADING HEEL BOOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462464 | MEDICHOICE ULTIMATE OFF LOADING | HEEL BOOT | FMP | SKIL-CARE CORP. | HPB 6300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |