FDA.reportPublic FDA data

MAUDE MDR 9908402

MDR report key
9908402
Report number
1645337-2020-04174
Event key
0
Event type
3
Date of event
2020-02-14
Date received
2020-03-31
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 MEMORYGEL BREAST IMPLANTPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLEDMENTOR TEXASFTR35430073543007148991N N

Patients#

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

Event Narratives#

N

Patient 1

SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER?S REFERENCE NUMBER: (B)(4).

D

Patient 1

IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANTS (300CC ON THE LEFT SIDE; 200CC ON THE RIGHT SIDE). THE PATIENT REPORTED THAT SHE WAS DIAGNOSED WITH RIGHT-SIDED BREAST CANCER ON (B)(6) 2020. SHE STATED THAT SHE WOULD HAVE TO GO INTO RADIATION BUT HER PHYSICIAN DOES NOT BELIEVE THAT HER IMPLANTS COULD HANDLE THE TREATMENT. SHE ALSO STATED THAT AN MRI ON (B)(6) 2020 CONFIRMED BILATERAL INTRACAPSULAR RUPTURE. AS A RESULT, THE PATIENT'S DEVICES WERE SCHEDULED FOR REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.