MAUDE MDR 9780624

MDR report key
9780624
Report number
3005883396-2020-00015
Event key
0
Event type
3
Date of event
2020-02-12
Date received
2020-03-03
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
LISA HERNANDEZ
Address
5920 LONGBOW DRIVE BOULDER CO 80301 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SITUATEGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLEMITG - RF SURGICAL SYSTEMSGDYG0404-16P01CN-1G0404-16P01CN-1191001KF* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-030

Event Narratives#

No narrative records found.