FDA.reportPublic FDA data

MAUDE MDR 9631433

MDR report key
9631433
Report number
9610773-2020-00054
Event key
0
Event type
3
Date of event
2020-01-15
Date received
2020-01-27
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 SHEATHRESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHSOLYMPUS WINTER & IBE GMBHFJLA22040AA22040A191WR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-270

Event Narratives#

No narrative records found.