FDA.reportPublic FDA data

MAUDE MDR 9555673

MDR report key
9555673
Report number
1219913-2020-00002
Event key
0
Event type
3
Date of event
2019-12-18
Date received
2020-01-06
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
MS. EIMAN SULIEMAN
Address
333 CONEY STREET E. WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATELLICA IM TOTAL HCG (THCG)TOTAL HCGSIEMENS HEALTHCARE DIAGNOSTICS, INC.JHIN/A1099569016093311R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-060

Event Narratives#

No narrative records found.