FDA.reportPublic FDA data

MAUDE MDR 9391589

MDR report key
9391589
Report number
9617229-2019-18801
Event key
0
Event type
3
Date of event
2019-10-28
Date received
2019-11-29
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
MRS. MICHELLE BURGESS
Address
301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US
Phone
737-737-7372
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STYLE 68 SALINE FILLED BREAST IMPLANTPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINEALLERGAN (COSTA RICA)FWM68-7003050449R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. R

Event Narratives#

No narrative records found.