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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR MEMORY SHAPE BREAST IMPLANT SILICONE GEL IMPLANTS

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MENTOR MENTOR MEMORY SHAPE BREAST IMPLANT SILICONE GEL IMPLANTS Back to Search Results
Model Number REF 354-1708
Device Problem Insufficient Information (3190)
Patient Problem Anaplastic Large Cell Lymphoma (3264)
Event Date 06/06/2017
Event Type  Injury  
Event Description
Pt with breast implants s/p reconstruction for cancer. Pt was three years out from exchange of implants. Pt developed fluid around right breast implant. Fluid eval done, pt found to have breast implant associated anaplastic large cell lymphoma. (bia-alcl). Implant and capsule removed. Pt found to have smooth gel implants- mentor memory shape breast implant.
 
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Brand NameMENTOR MEMORY SHAPE BREAST IMPLANT
Type of DeviceSILICONE GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6849535
MDR Text Key85165963
Report NumberMW5072020
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/06/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREF 354-1708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/07/2017 Patient Sequence Number: 1
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