MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-21 for MEDCHOICE ULTIMATE OFF-LOADING HEEL BOOT HPB6300 manufactured by Owens And Minor/medichoice.
[4497740]
On the evening of (b)(6) 2014 a (b)(6) male (patient (b)(6)) was a (b)(6) inpatient on a medical floor awaiting placement at a skilled nursing facility. Throughout his admission, (b)(6) had been alert and cooperative, using his call bell for assistance when needing to move the commode or chair. This evening he was alert, sitting on the side of the bed eating dinner with the call bell in reach. Medi-choice ultimate off-loading heel boots were in place, and he had stated understanding he was not to attempt to walk in these boots. Fifteen minutes later (b)(6) was found on the floor near the far wall in the middle of the room, with a head laceration and confusion. His boots were in place when he was found. It is unclear if (b)(6) became confused prior to the fall, or why he walked across the room with his call bell still on the bed. Pt (b)(6) was found to have sustained extensive intracranial hemorrhage during the fall, and he died on (b)(6) 2014. Dates of use: two hours. Diagnosis: newly identified open area on one heel.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5036208 |
MDR Report Key | 3833655 |
Date Received | 2014-05-21 |
Date of Report | 2014-05-19 |
Date of Event | 2014-05-07 |
Date Added to Maude | 2014-05-28 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MEDCHOICE ULTIMATE OFF-LOADING HEEL BOOT |
Generic Name | HEEL BOOTS |
Product Code | FMP |
Date Received | 2014-05-21 |
Model Number | HPB6300 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OWENS AND MINOR/MEDICHOICE |
Manufacturer Address | MECHANICSVILLE 23116 23116 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death | 2014-05-21 |