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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POLYMER COMPOSITE

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POLYMER COMPOSITE Back to Search Results
Device Problem Output Problem (3005)
Patient Problems Headache (1880); Nausea (1970); Complaint, Ill-Defined (2331); Confusion/ Disorientation (2553)
Event Type  Injury  
Event Description
Exposure to nanobiologics x 12 years.Medical battery performed by physician/spouse.Polymer silicon exposure, causing, nausea, headaches, mental confusion, subsequent multiple hospitalizations.Now deformities in scalp tissue area concern for signs/symptoms of silicosis.
 
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Brand Name
POLYMER COMPOSITE
Type of Device
POLYMER COMPOSITE
MDR Report Key4960373
MDR Text Key21771249
Report NumberMW5045007
Device Sequence Number1
Product Code EBF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2015
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age44 YR
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