FDA.reportPublic FDA data

MAUDE MDR 276763

MDR report key
276763
Report number
1059332-2000-00001
Event key
0
Event type
3
Date of event
2000-02-16
Date received
2000-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
4320 INTERNATIONAL BLVD NORCROSS GA 30093 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMS 2400SHARPS CONTAINER CLASS IIISOLYSER CO.MMKSMS 2400**NNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-05-0401. O

Event Narratives#

D

Patient 1

SMS 2400 RUPTURED AFTER CATALYST ADDED.