MENTOR SMOOTH ROUND MODERATE PROFILE 3501697

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 SMOOTH ROUND MODERATE PROFILE 3501697 manufactured by Mentor Texas.

Event Text Entries

[186202693] 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: left breast prosthesis deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186202734] It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast reconstruction procedure with a mentor smooth round moderate profile 700cc saline breast prosthesis that deflated after implantation. Deflation of the patient? S left breast prosthesis was confirmed by a doctor? S physical examination. As a result, the patient will undergo explantation on (b)(6) 2020. The reported implantation date is after the expiration date of the device. The implantation date will be reported as received by mentor. If clarification on the implantation date is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-05143
MDR Report Key9908861
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-02-01
Date Mfgr Received2020-03-12
Device Manufacturer Date2006-07-29
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 SMOOTH ROUND MODERATE PROFILE
Generic NamePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Product CodeFWM
Date Received2020-03-31
Model Number3501697
Catalog Number3501697
Lot Number5695559
Device Expiration Date2010-07-28
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. Required No Informationntervention 2020-03-31

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