FDA.reportPublic FDA data

MAUDE MDR 9908095

MDR report key
9908095
Report number
9617229-2020-05192
Event key
0
Event type
3
Date of event
2020-01-05
Date received
2020-03-31
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
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
1INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANTPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLEDALLERGAN (COSTA RICA)FTRN-TSF3652935968R N

Patients#

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

Event Narratives#

N

Patient 1

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 "THE ULTRASOUND SHOWS A RUPTURE ON THE LEFT SIDE." THE DEVICE HAS BEEN EXPLANTED.