FDA.reportPublic FDA data

MAUDE MDR 8516588

MDR report key
8516588
Report number
2438477-2019-00021
Event key
0
Event type
3
Date received
2019-04-15
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#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIVECRUTCHDANYANG JUMAOIPR10502-1* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1501. R

Event Narratives#

D

Patient 1

(B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CRUTCH. THE CONSUMER RECEIVED THE CRUTCH FROM A HOSPITAL. HE NOTICED THAT THE BOLT ON THE CRUTCH WAS MISSING. WHEN HE USED THE CRUTCH IT SNAPPED. HE FELL. HE FRACTURED HIS LEG IN TWO ADDITIONAL PLACES.