FDA.reportPublic FDA data

MAUDE MDR 6845380

MDR report key
6845380
Report number
2020362-2017-00064
Event key
0
Event type
3
Date received
2017-09-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
WILLIAM HINCY
Address
POSEY PRODUCTS LLC 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
1METAL BUCKLE GAIT BELT, STANDARD WHITEAID, TRANSFERPOSEY PRODUCTS LLCIKX65246524UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-060

Event Narratives#

N

Patient 1

THIS REPORT IS BASED SOLELY ON A PRODUCT REVIEW AND NO INCIDENTS WERE REPORTED. IF THE BUCKLE(S) PRE-RELEASES OR IS BACKWARDS, THE COMPLAINT IS REPORTABLE. THESE CONDITIONS MAY ALLOW THE BUCKLE TO INITIALLY CLOSE BUT IT IS POSSIBLE THAT THE BUCKLE COULD LATER UNLATCH WHILE IN USE. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE APPLICATION INSTRUCTIONS CAUTION THE USER TO 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. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NONCONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, 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 AT THIS TIME. (B)(4). DEVICE NOT AVAILABLE. CUSTOMER REVIEW.

D

Patient 1

POST MARKET SURVEILLANCE SEARCH ON (B)(6) FOUND SEVERAL REPORTS ABOUT THE POSEY GAIT BELTS: BUCKLE WAS SEWN ON WRONG, THE QUICK RELEASE BUCKLE DOES NOT HOLD WHEN TIGHTENED. THE DATE THESE ISSUE WERE DISCOVERED IS UNKNOWN AND NO INCIDENTS OR INJURIES WERE REPORTED.