MAUDE Adverse Event Report: POLYMER COMPOSITE

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.

• Brand Name: POLYMER COMPOSITE
• Type of Device: POLYMER COMPOSITE
• MDR Report Key: 4960373
• MDR Text Key: 21771249
• Report Number: MW5045007
• Device Sequence Number: 1
• Product Code: EBF
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/28/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 44 YR