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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SX RND MPP GEL-FILLED MAMMORY PROSTH GEL-FILLED BREAST IMPLANT: DEVICE 1 -2"

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MENTOR SX RND MPP GEL-FILLED MAMMORY PROSTH GEL-FILLED BREAST IMPLANT: DEVICE 1 -2" Back to Search Results
Lot Number 265879
Event Date 03/15/2016
Event Type  Injury  
Event Description

I have breast implants since 1993. In 2016 i had a breast reduction with old implants removed and new implants to put in. I was diagnosed with alcl in 2016. Went through chemo then had a stem cell transplant in (b)(6) 2016.

 
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Brand NameSX RND MPP GEL-FILLED MAMMORY PROSTH
Type of DeviceGEL-FILLED BREAST IMPLANT: DEVICE 1 -2"
Manufacturer (Section D)
MENTOR
MDR Report Key6436022
Report NumberMW5068673
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/24/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number265879
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: 03/24/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: NONE
RX MEDS: SYNTHROID 88 MCG
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