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Adverse Event Report

DOW CORNING CORP SILASTIC VARIFIL MAMMARY IMPLANT INFLATABL MAM IMP SALINE-FILLED   back to search results
Event Date 05/23/1995
Event Type  Injury   Patient Outcome  Other; Disability
Event Description

Report alleges pt complains that the right breast has been smaller for a few years but denies history of trauma. The left side encapsulated one year after symptoms. Report also alleges pt had moderate local pain with the left being greater than the right. The pt's main concern is systemic problems which have developed in the last four years. These include arthralgias (upper greater than lower with morning stiffness)/myalgias, paresthesias/dysesthesias, spasms, fatigue, sleep disturbances, sore throats, frequent sinusitis, headaches, visual changes, dizziness, memory loss, hair loss, itching, photophobia, and miscarriage. Pt is otherwise healthy.

 
Manufacturer Narrative

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

 
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Brand NameSILASTIC VARIFIL MAMMARY IMPLANT INFLATABL
Type of DeviceMAM IMP SALINE-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 Key280819
MDR Report Key303901
Event Key272329
Report Number1816403-2000-00144
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2000
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 Other
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 February 28, 2009

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