MAUDE MDR 8666543

MDR report key
8666543
Report number
1216677-2018-00037
Event key
0
Event type
3
Date of event
2018-05-14
Date received
2019-06-04
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
MR. PETER NIZIOLEK NIZIOLEK
Address
75 CORPORATE DRIVE - TRUMBULL CT 06611 US
Phone
203-203-2036
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
182420 - SANI-SCOPE DISP ANOSCOPE82420 - SANI-SCOPE DISP ANOSCOPECOOPERSURGICAL, INC.HIB8242082420UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-0401. O

Event Narratives#

No narrative records found.