FDA.reportPublic FDA data

MAUDE MDR 5943487

MDR report key
5943487
Report number
9616086-2016-00024
Event key
0
Event type
3
Date of event
2012-08-05
Date received
2016-09-12
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 FISHER
Address
1430 DECISION STREET VISTA CA 92081 US
Phone
760-760-7607
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AIRCASTANKLE BRACEDJO, LLCITW02ARR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1201. O

Event Narratives#

N

Patient 1

NOT RETURNED.

D

Patient 1

COMPLAINT RECEIVED THAT ALLEGES "4 MONTHS AFTER HAVING WORN A STIRRUP IN 2012, A PATIENT HAD A BRAIN STROKE. THE PATIENT INDICATED THEY BELIEVE THE ANKLE BRACE CONTRIBUTED TO THE STROKE". QUESTIONNAIRE WAS RECEIVED FROM CUSTOMER OR CLINICIAN, HOWEVER NO ADDITIONAL INFORMATION WAS INCLUDED IN THE RESPONSE. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.