MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-07 for MEDICHOICE ULTIMATE OFF LOADING HPB 6300 manufactured by Skil-care Corp..
[5102960]
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.
Patient Sequence No: 1, Text Type: D, B5
[12364528]
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".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431497-2014-00001 |
| MDR Report Key | 4184189 |
| Report Source | 08 |
| Date Received | 2014-08-07 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-05-07 |
| Date Facility Aware | 2014-07-25 |
| Report Date | 2014-08-06 |
| Date Reported to FDA | 2014-06-08 |
| Date Mfgr Received | 2014-07-25 |
| Date Added to Maude | 2014-10-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARTIN PRENSKIE |
| Manufacturer Street | 29 WELLS AVE. |
| Manufacturer City | YONKERS NY 10701 |
| Manufacturer Country | US |
| Manufacturer Postal | 10701 |
| Manufacturer Phone | 9149632040 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE ULTIMATE OFF LOADING |
| Generic Name | HEEL BOOT |
| Product Code | FMP |
| Date Received | 2014-08-07 |
| Model Number | HPB 6300 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKIL-CARE CORP. |
| Manufacturer Address | YONKERS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-08-07 |