FDA.reportPublic FDA data

MAUDE MDR 9203577

MDR report key
9203577
Report number
1216677-2019-00279
Event key
0
Event type
3
Date of event
2019-08-26
Date received
2019-10-17
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
Address
50 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
1LEEP GRAVES SPEC MEDLEEP GRAVES SPEC MEDCOOPERSURGICAL, INC.HDF6151461514NONEN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-1701. O

Event Narratives#

No narrative records found.