FDA.reportPublic FDA data

MAUDE MDR 9856656

MDR report key
9856656
Report number
1221934-2020-00918
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GII QA+ #2 ETH CP-2 *EASOFT-TISSUE ANCHOR, NON-BIOABSORBABLEDEPUY MITEK LLC USJDR2120342120343L87729R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-190

Event Narratives#

No narrative records found.