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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CONTOUR PROFILE SILTEX SALINE FILLED BREAST IMPLANTS

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MENTOR CONTOUR PROFILE SILTEX SALINE FILLED BREAST IMPLANTS Back to Search Results
Catalog Number 354-2711
Event Date 01/05/2017
Event Type  Injury  
Event Description

I have had mentor textured implants for 19 years. From the moment they were inserted under the muscle i had allergic type reaction. Subsided after 7 months of treatment. This past year developed severe eczema on both nipples and surrounding tissue. Eczema on about 50 percent of my body as well. Explanted (b)(6). By (b)(6).

 
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Brand NameCONTOUR PROFILE SILTEX SALINE FILLED
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7027561
Report NumberMW5073307
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/11/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received11/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number354-2711
Device LOT Number154574
Was Device Available For Evaluation? No
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: 11/13/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: NA.
RX MEDS: ZRYTEC 10MG DAILY.
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