FDA.reportPublic FDA data

MAUDE MDR 9622949

MDR report key
9622949
Report number
MW5092460
Event key
0
Event type
3
Date of event
2020-01-17
Date received
2020-01-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCULOC GAIT BELTAID, TRANSFERUNKNOWNIKXI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-220

Event Narratives#

D

Patient 1

GAIT BELT ON PATIENT BY PHYSICAL THERAPY. PT ATTEMPTED TO HELP PATIENT USING THE GAIT BELT. AS THE PATIENT WAS BEGINNING TO STAND, THE GAIT BELT SLID OPEN AND WILL NOT STAY TIGHT ON PATIENT. PATIENT WAS UNHARMED AND DID NOT FALL. FDA SAFETY REPORT ID # (B)(4).