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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MOD PLUS PROFILE - SALINE BREAST IMPLANTS

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MENTOR SMOOTH ROUND MOD PLUS PROFILE - SALINE BREAST IMPLANTS Back to Search Results
Model Number 350-2450
Event Date 01/01/2016
Event Type  Injury  
Event Description

Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain - left side, heart palpitations.

 
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Brand NameSMOOTH ROUND MOD PLUS PROFILE - SALINE
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6669671
Report NumberMW5070658
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation Patient
Report Date 06/24/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-2450
Device LOT Number6460261
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/24/2017 Patient Sequence Number: 1
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