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Adverse Event Report

BAXTER V. MUELLER DOUBLE LUMEN BREAST IMPLANT WITH POLYURETHANE   back to search results
Catalog Number HS360-6450;M
Patient Outcome  Disability;
Event Description

In 1979 rptr had double mastectomy & breast implant with double lumen implants. In 1985 she had explantation due to one rupture & subsequent implanting of another mfr's silicone gel breast implants. Now she is unable to work because of poor memory, lack of energy & aches & pains. She was diagnosed with sjogren's disease, thyroid problems, autoimmune disease, myalgias, & dry eyes & mouth. Costo chondritis. She has muscle cramps, heart palpitations, & arm weakness & numbness. The 1994 explant pathology report noted "chronic inflammation & foamy histiocytes consistent with silicone bleed. ".

 
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Brand NameDOUBLE LUMEN BREAST IMPLANT WITH POLYURETHANE
Type of DeviceBREAST IMPLANT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER V. MUELLER
mcgaw park IL 60085
Device Event Key26294
MDR Report Key25718
Event Key23947
Report NumberMW1006942
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 09/02/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/1995
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHS360-6450;M
Device LOT NumberHS173565
OTHER Device ID NumberHS6000 MP OVAL;
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Yes

Database last updated on January 30, 2009

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