FDA.reportPublic FDA data

MAUDE MDR 9717307

MDR report key
9717307
Report number
3008579854-2020-00004
Event key
0
Event type
3
Date of event
2020-02-07
Date received
2020-02-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BRIAN BECKER
Address
2900 LAKE VISTA DRIVE LEWISVILLE, TX US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DR COMFORT L5000 TOE FILLER CUSTOM INSOLEORTHOSIS, CORRECTIVE SHOEDJO, LLCKNP17-0004-0-00000Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1701. R

Event Narratives#

N

Patient 1

NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

D

Patient 1

IT WAS REPORTED THAT THE "INSERT CAUSED AN ULCER AT 1ST METATARSAL AREA... AN OPEN WOUND BEING TREATED BY DOCTOR". NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.