FDA.reportPublic FDA data

MAUDE MDR 9842822

MDR report key
9842822
Report number
2529571-2020-00003
Event key
0
Event type
3
Date of event
2017-07-24
Date received
2020-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. STEPHEN MCKINLEY
Address
923 EAST WELLSPRING RD. NEW FREEDOM PA 17249 US
Phone
717-717-7172
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OAKWORKS MEDICAL CFPM 400 IMAGING TABLEIMAGING TABLEOAKWORKS INC.IXRCFPM 40075204-T01N/AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-170

Event Narratives#

No narrative records found.