MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for MENTOR MEMORYGEL BREAST IMPLANT 3543007 manufactured by Mentor Texas.

Event Text Entries

[185864682] 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).
Patient Sequence No: 1, Text Type: N, H10

[185864683] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1645337-2020-04174
MDR Report Key9908402
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-11
Date of Event2020-02-14
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal75038
Manufacturer Phone949789-868
Manufacturer G1MENTOR TEXAS
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeFTR
Date Received2020-03-31
Model Number3543007
Catalog Number3543007
Lot Number148991
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMENTOR TEXAS
Manufacturer Address3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038


Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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