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Adverse Event Report

DOW CORNING CORP. SILASTIC ROUND BREAST IMPLANT, 340 CC   back to search results
Catalog Number 977
Event Description

Pt experienced lung granuloma, lack of energy, headaches, arm pain, back pain, right axilla pain, arthritic shoulder and elbow, arthralgia, breast lumps, tender nipples, flu symptoms, right breast firmness and tenderness with shifting and distortion, capsular contractures, elbow pain, joint pain, morning stiffness, cervical myalgia, fibrositis, breast asymmetry and hardening, carpal tunnel syndrome, arthritis, joint swelling, muscle fatigue, breast tenderness, fatigue, general aching and stiffness, crooked implants, possible implant leakage, shoulder and arm pain. This info was submitted as follow-up 11/9/94: pt has developed rheumatoid arthritis.

 
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Brand NameSILASTIC ROUND BREAST IMPLANT, 340 CC
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING CORP.
midland MI 48686
Device Event Key11873
MDR Report Key11873
Event Key7968
Report NumberMW1000985
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 03/02/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/1994
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device Catalogue Number977
Device LOT NumberHH112436
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 06, 2009

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