MAUDE MDR 9548043

MDR report key
9548043
Report number
0001526350-2020-00015
Event key
0
Event type
3
Date received
2020-01-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
134IN. (86CM) A.T.S. CYLINDRICAL CUFF - DP, SBTOURNIQUET, PNEUMATICZIMMER SURGICAL, INC.KCYN/A60750000600Z000004201Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-030

Event Narratives#

No narrative records found.