FDA.reportPublic FDA data

MAUDE MDR 9521571

MDR report key
9521571
Report number
0001526350-2019-01196
Event key
0
Event type
3
Date of event
2019-12-04
Date received
2019-12-26
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. CHRISTINA ARNT
Address
56 E. BELL DRIVE WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATS3000 ITALIANTOURNIQUET, PNEUMATICZIMMER SURGICAL, INC.KCYN/A6030003010562236086Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-260

Event Narratives#

No narrative records found.