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Adverse Event Report

DOW CORNING DOW CORNING GEL BREAST IMPLANTS   back to search results
Patient Outcome  Other; Disability
Event Description

"s/p b submusc transax dc salines for augmentation. Pt c/o r being smaller x "a few yrs," but denies decreased size or h/o trauma. The l encapsulated 1 yr after sx. Had mod local pain l greater than r. Main concern is systemic probs which have developed in last 4 yrs. These include arthralgias (upper greater than lower with + am stiffness)/myalgias, paresthesias/dysesthesias, spasms, fatigue, sleep disturb, sore throats, frequent sinusitis, headaches, visual changes, dizziness, memory loss, hair loss, itching, photophobia and miscarriage. Pt is otherwise healthy. ".

 
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Brand NameDOW CORNING
Type of DeviceGEL BREAST IMPLANTS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING
*
Device Event Key280819
MDR Report Key290161
Event Key272329
Report NumberMW1019595
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 07/18/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available For Evaluation? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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