MENTOR SMOOTH ROUND HIGH PROFILE 3503630

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 2019-11-29 for MENTOR SMOOTH ROUND HIGH PROFILE 3503630 manufactured by Mentor Texas.

MAUDE Entry Details

Report Number1645337-2019-24743
MDR Report Key9392105
Report SourceCONSUMER
Date Received2019-11-29
Date of Report2019-11-07
Date of Event2019-03-01
Date Mfgr Received2019-11-07
Device Manufacturer Date2018-02-06
Date Added to Maude2019-11-29
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 HIGH PROFILE
Generic NamePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Product CodeFWM
Date Received2019-11-29
Catalog Number3503630
Lot Number7544407
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 2019-11-29

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