FDA.reportPublic FDA data

MAUDE MDR 9908816

MDR report key
9908816
Report number
9617229-2020-04942
Event key
0
Event type
3
Date of event
2020-01-23
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. MICHELLE BURGESS
Address
12331-A RIATA TRACE PARKWAY BUILDING 3 AUSTIN TX 78727 US
Phone
737-737-7372
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANTPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLEDALLERGAN (COSTA RICA)FTRN-27-MX130-4102713300R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.

D

Patient 1

PHYSICIAN REPORTS RUPTURE. THE DEVICE SIDE AND STATUS ARE UNKNOWN.