MAUDE MDR 9243966

MDR report key
9243966
Report number
3008579854-2019-00015
Event key
0
Event type
3
Date of event
2019-10-04
Date received
2019-10-28
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
MR. BRIAN BECKER
Address
2900 LAKE VISTA DRIVE LEWISVILLE TX 75067 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DR. COMFORT PERFORMANCE BLACK 10.0 WDORTHOSIS, CORRECTIVE SHOEDJO, LLCKNP7611-W-10.0Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-2801. R

Event Narratives#

No narrative records found.