FDA.reportPublic FDA data

MAUDE MDR 6655923

MDR report key
6655923
Report number
2020362-2017-00031
Event key
0
Event type
3
Date received
2017-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
WILLIAM HINCY
Address
POSEY COMPANY 5635 PECK ROAD ARCADIA CA 91006 US
Phone
626-626-6264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SINGLE PATIENT USE GAIT BELTAID, TRANSFERPOSEY PRODUCT LLCIKX65566556UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-200

Event Narratives#

N

Patient 1

(B)(4). HISTORICAL DATA FOUND SIMILAR RESULTS OF "SLIPPAGE", HOWEVER THE REPORTED ISSUE COULD NOT BE CONFIRMED. INTERNAL INVESTIGATIONS FOUND THE DEVICE FUNCTIONS AS EXPECTED AND DOES NOT SLIP IF ALL THE APPLICATION INSTRUCTIONS ARE FOLLOWED. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED ISSUE, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. THE IFU STATES: "ALWAYS INSPECT BEFORE EACH USE: CHECK FOR BROKEN STITCHES OR PARTS; TORN, CUT OR FRAYED MATERIAL; OR BUCKLES THAT ARE CRACKED OR BROKEN AND DO NOT HOLD SECURELY. NEVER USE SOILED OR DAMAGED PRODUCTS." ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. (B)(4). PRODUCT WILL NOT BE RETURNED.

D

Patient 1

CUSTOMER REPORTED THE GAIT BELT BECOMES LOOSE WHEN IN USE WITH A PATIENT. THE GAIT BELT IS NO LONGER SNUG. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INJURIES WERE REPORTED.