MENTOR MEMORYGEL BREAST IMPLANT 3507320MC

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 3507320MC manufactured by Mentor Texas.

Event Text Entries

[185864191] 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


[185864192] It was reported that a (b)(6) year-old female patient who underwent a breast augmentation primary with 320cc smooth mentor memorygel breast implant has experienced postoperative right-sided implant rupture. Rupture was discovered during revision surgery. The patient underwent explantation and replacement with like device, catalog # 3507320mc, serial # (b)(4) on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-05127
MDR Report Key9908313
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-10
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2016-03-05
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 Number3507320MC
Catalog Number3507320MC
Lot Number7301267
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. Required No Informationntervention 2020-03-31

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