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Adverse Event Report

DOW CORNING CORP. SILASTIC MAMMARY IMPLANT MAM IMP GEL-FILLED   back to search results
Event Date 03/21/1995
Event Type  Injury   Patient Outcome  Other; Disability
Event Description

Report alleges pt's left implant is firmer although more moveable and has possibly decreased in size with no history of trauma and pt has had two closed capsulotomies early on. Pt has been diagnosed with scleroderma, crest, complains of arthralgias, myalgias, swelling, fatigue, adenopathy, hot flashes/sweats/chills, headaches, tmj disease, severe dental problems, dizziness, memory loss, dry mucus membranes, raynaud's with ulcerations, sensitivity to chemical/cold, shortness of breath, costochondritis, varicosities, choking sensation, gastrointestinal/genitourinary problems and onycholysis. Pt is otherwise healthy.

 
Manufacturer Narrative

Rptr and pt are anonymous; therefore, no investigation can be done.

 
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Brand NameSILASTIC MAMMARY IMPLANT
Type of DeviceMAM IMP GEL-FILLED
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DOW CORNING CORP.
1635 n. gleaner road
hemlock MI 48626
Manufacturer (Section D)
DOW CORNING CORP.
1635 n. gleaner road
hemlock MI 48626
Manufacturer Contact
jan classens
2200 w salzburg rd
midland , MI 48686-0994
(517) 496 -8724
Device Event Key281367
MDR Report Key304101
Event Key272875
Report Number1816403-2000-00128
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NOT APPLICABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/11/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on December 31, 2008

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