FDA.reportPublic FDA data

MAUDE MDR 8949203

MDR report key
8949203
Report number
1216677-2019-00239
Event key
0
Event type
3
Date of event
2019-08-22
Date received
2019-08-30
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 VU-MAX GRAVES LARGELEEP VU-MAX GRAVES LARGECOOPERSURGICAL, INC.HDFF219F22191807232Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-3001. O

Event Narratives#

No narrative records found.