MENTOR MEMORYGEL BREAST IMPLANT SHPX490

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for MENTOR MEMORYGEL BREAST IMPLANT SHPX490 manufactured by Mentor Texas.

Event Text Entries

[185864494] The mentor failure analysis lab has received the device for evaluation. The analysis has begun but is not complete at this time. When the investigational analysis has been completed, a supplemental report will be submitted. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: right breast capsular contracture. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185864495] It was reported that a (b)(6) year-old female patient who underwent a primary breast augmentation procedure with a mentor memorygel breast implant 490cc gel breast prosthesis developed baker grade iv capsular contracture in her right breast. As a result, the patient underwent explantation on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-05128
MDR Report Key9908274
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-11
Date of Event2020-03-06
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-01-02
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
Returned To Mfg2020-03-20
Model NumberSHPX490
Catalog NumberSHPX490
Lot Number7669587
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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. Required No Informationntervention 2020-03-31

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