MENTOR MEMORYGEL BREAST IMPLANT 3507004BC

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 3507004BC manufactured by Mentor Texas.

Event Text Entries

[185864679] At the time of this report, mentor has received no information regarding explantation or an expected explantation date. It is unknown at this time if the device will be made available for return. As a result, 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: n/a. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185864680] It was reported that a caucasian female patient who underwent primary breast reconstruction surgery with a 700cc mentor memorygel breast implant experienced anxiety, depression, induced diabetes, fatty liver, joint pain, arthritis, left implant sitting on nerve, pain, brain fog, insomnia, inflammation, underarm pain, fatigue post procedure. Patient had a surgical procedure on an unknown date to remove lymph nodes but still has pain under her arm. At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-05132
MDR Report Key9908387
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-09
Date of Event2013-03-11
Date Mfgr Received2020-03-09
Device Manufacturer Date2013-02-12
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

Brand NameMENTOR MEMORYGEL BREAST IMPLANT
Generic NamePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Product CodeFTR
Date Received2020-03-31
Model Number3507004BC
Catalog Number3507004BC
Lot Number6680890
Device Expiration Date2018-02-28
OperatorHEALTH PROFESSIONAL
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


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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