FDA.reportPublic FDA data

MAUDE MDR 9908479

MDR report key
9908479
Report number
1645337-2020-05065
Event key
0
Event type
3
Date of event
2020-02-19
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 TEXASFTR3503754BC3503754BC7682655N 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: CAPSULAR CONTRACTURE. MANUFACTURER?S REFERENCE NUMBER: (B)(6).

D

Patient 1

IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE III CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2020.