FDA.reportPublic FDA data

MAUDE MDR 9392274

MDR report key
9392274
Report number
1645337-2019-24752
Event key
0
Event type
3
Date of event
2019-11-04
Date received
2019-11-30
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. GABRIEL ALFAGEME
Address
3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MENTOR SILTEX ROUND MODERATE PROFILEPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINEMENTOR TEXASFWM35426506479211N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-3001. R

Event Narratives#

No narrative records found.