FDA.reportPublic FDA data

MAUDE MDR 9178790

MDR report key
9178790
Report number
2126666-2019-00069
Event key
0
Event type
3
Date of event
2019-08-23
Date received
2019-10-11
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
SHARON SEIFERT
Address
340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US
Phone
952-952-9526
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZIPWIRE HYDROPHILIC GUIDEWIREUROLOGICAL CATHETER AND ACCESSORIESLAKE REGION MEDICALEZBY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-110

Event Narratives#

No narrative records found.