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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS

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MENTOR MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS Back to Search Results
Model Number REF 350-3330
Event Date 10/13/2010
Event Type  Injury  
Event Description

My gallbladder had to be removed, due to it working only at 11% after nuclear testing. Severe pain in breasts started in 2016 along with drastic weight loss. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. Right had capsular contracture.

 
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Brand NameMENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
Type of DeviceMENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6961135
Report NumberMW5072836
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/17/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberREF 350-3330
Device LOT Number5840510
Was Device Available For Evaluation? Yes
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: 10/19/2017 Patient Sequence Number: 1
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