FDA.reportPublic FDA data

MAUDE MDR 8498251

MDR report key
8498251
Report number
2020362-2019-00073
Event key
0
Event type
3
Date received
2019-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1MITTS- NO FINGER SEPARATORSRESTRAINT, PROTECTIVEPOSEY PRODUCTS LLCFMQ28112811R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1001. O

Event Narratives#

N

Patient 1

THE CUSTOMER CONFIRMED THEY WILL NOT BE RETURNING THE DEVICE. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. HISTORICAL REVIEW OF THE COMPLAINT DATABASE FOUND 4 OTHER EVENT WITH SIMILAR ISSUE WHERE THE PATIENTS WERE ABLE TO MANEUVER AROUND THE MITTS. OF THE 4 COMPLAINTS, PRODUCT WAS RETURNED FOR ONLY ONE OF THE COMPLAINT. ANALYSIS OF THE DEVICE FOUND IT TO HAVE MET SPECIFICATIONS AND FUNCTIONED AS DESIGNED. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY 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. 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).

D

Patient 1

CUSTOMER REPORTED THE PATIENT WAS ABLE TO SELF-RELEASE FROM THE MITT AND REMOVE HIS/HER CHEST-TUBE. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED SHE DO NOT BELIEVE THE ISSUE IS RELATED TO ANY SPECIFIC PRODUCT FAILURE. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN.