FDA.reportPublic FDA data

MAUDE MDR 8956671

MDR report key
8956671
Report number
1217183-2019-00004
Event key
0
Event type
3
Date of event
2019-08-11
Date received
2019-09-03
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
MS. REBA DAOUST
Address
180 HARTWELL ROAD BEDFORD MA 01730 US
Phone
781-781-7818
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACL TOP 500 CTSINSTRUMENT, COAGULATION, AUTOMATED, PRODUCT CODE: GKPINSTRUMENTATION LABORATORYGKP2800-4000000280040Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-0301. O

Event Narratives#

No narrative records found.