FDA.reportPublic FDA data

MAUDE MDR 5702730

MDR report key
5702730
Report number
MW5062682
Event key
0
Event type
3
Date of event
2016-05-12
Date received
2016-06-03
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
1POSEY NONSKID SOCKSNONSKID SOCKSPOSEY COMPANYFQL6239R* Y
2POSEY NONSKID SOCKSNONSKID SOCKSPOSEY COMPANYFQL6239Y* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-0301. R

Event Narratives#

D

Patient 1

THE NON-SKID PADS ON THE BOTTOM OF THE POSEY SOCKS THAT ARE USED FOR OUR HIGH FALL RISK PATIENTS DID NOT HAVE ENOUGH NON-SKID MATERIAL CAUSING THE SOCK TO BE SLIPPERY AND INCREASE THE RISK FOR FALLS. THE COMPANY WAS MADE AWARE WHEN IT WAS REALIZED THAT POTENTIALLY 2 PATIENTS HAD BEEN AFFECTED BY THE DEFECT. WE ARE UNSURE HOW LONG THIS HAD BEEN OCCURRING.