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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Anaplastic Large Cell Lymphoma (3264)
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
MDR Text Key70908687
Report NumberMW5068673
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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
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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