FDA.reportPublic FDA data

MAUDE MDR 9701909

MDR report key
9701909
Report number
9610773-2020-00069
Event key
0
Event type
3
Date of event
2020-01-29
Date received
2020-02-12
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
MR. DANIEL WLADOW
Address
KUEHNSTRASSE 61 HAMBURG 22045 GM
Phone
494-494-4940
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INNER SHEATH, FOR 26 FR. OUTER SHEATHINNER SHEATHOLYMPUS WINTER & IBE GMBHHIHA22040AA22040A174W-0191Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-120

Event Narratives#

No narrative records found.