FDA.reportPublic FDA data

MAUDE MDR 9793829

MDR report key
9793829
Report number
1216677-2020-00075
Event key
0
Event type
3
Date of event
2020-02-25
Date received
2020-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PETER NIZIOLEK
Address
50 CORPORATE DRIVE TRUMBULL, CT US
Phone
601-601-6015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MYSTIC II,MUSHROOM CUPMYSTIC II,MUSHROOM CUPCOOPERSURGICAL INC.HDB1005710057UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-050

Event Narratives#

No narrative records found.