FDA.reportPublic FDA data

MAUDE MDR 9181567

MDR report key
9181567
Report number
1063481-2019-00062
Event key
0
Event type
3
Date of event
2018-09-24
Date received
2019-10-11
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
ROCHELLE MANEY
Address
1655 ROBERTS BLVD., NW KENNESAW GA 30144 US
Phone
770-770-7704
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHOTOFIX PATCH - 6CM X 8CMPHOTOFIX DECELLULARIZED BOVINE PERICARDIUMCRYOLIFE, INC.PSQPFP 6X8PFP 6x8PF15120N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-1101. O

Event Narratives#

No narrative records found.