FDA.reportPublic FDA data

MAUDE MDR 6845156

MDR report key
6845156
Report number
2020362-2017-00063
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
1TRANSFER BELT, QUICK-RELEASE ECONOMYAID, TRANSFERPOSEY PRODUCTS LLCIKX6537Q6537QUNKN 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 BELT SLIDES OR THE BUCKLE LOOSENS, IT MAY ALLOW THE UNINTENTIONAL RELEASE OF THE PATIENT. 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 CHECK FOR SKIN INTEGRITY, PROPER CIRCULATION AND RANGE OF MOTION WHEN THE BELT IS IN USE. ENSURE THAT THE BELT IS SECURE AND DOES NOT COMPROMISE THE PATIENT?S MEDICAL CONDITION AND DOES NOT INTERFERE WITH TUBES, LINES OR OTHER EQUIPMENT. 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 A REVIEW THAT THE POSEY TRANSFER BELT SLIDES WHEN IN USE AND THE BUCKLE BECOMES LOOSE FAST. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT WERE REPORTED.