MEDCHOICE ULTIMATE OFF-LOADING HEEL BOOT HPB6300

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5036208
MDR Report Key3833655
Date Received2014-05-21
Date of Report2014-05-19
Date of Event2014-05-07
Date Added to Maude2014-05-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDCHOICE ULTIMATE OFF-LOADING HEEL BOOT
Generic NameHEEL BOOTS
Product CodeFMP
Date Received2014-05-21
Model NumberHPB6300
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerOWENS AND MINOR/MEDICHOICE
Manufacturer AddressMECHANICSVILLE 23116 23116


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-05-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.