TEN20 CONDUCTIVE PASTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-22 for TEN20 CONDUCTIVE PASTE * manufactured by D. O. Weaver And Company.

Event Text Entries

[21985130] Patient wrote complaint letter to the hospital stating that she had experienced significant hair loss where the eeg electrodes had been glued to her head (on the seizure monitoring unit). Patient had been hospitalized for 8 days and noted the hair loss after she was home from the hospital. Patient also e-mailed several pictures of the bald spots on her head (where electrodes had been glued). Patients sign a form describing the risks of epliepsy monitoring, which specifically states that "... Small patches of hair are sometimes lost. " however, the patient's pictures show more than small patches of hair were lost.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2471338
• MDR Report Key: 2471338
• Date Received: 2012-02-22
• Date of Report: 2012-02-07
• Date of Event: 2011-11-29
• Report Date: 2012-02-07
• Date Reported to FDA: 2012-02-22
• Date Added to Maude: 2012-02-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TEN20 CONDUCTIVE PASTE
• Generic Name: CONDUCTIVE PASTE, EEG MONITORING
• Product Code: GYB
• Date Received: 2012-02-22
• Model Number: *
• Catalog Number: TEN20 CONDUCTIVE PASTE
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: D. O. WEAVER AND COMPANY
• Manufacturer Address: 565 NUCLA WAY UNIT B AURORA CO 80011 US 80011

Device Sequence Number: 2

• Brand Name: COLLODION USP
• Generic Name: COLLODIAN, USP
• Product Code: GYB
• Date Received: 2012-02-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS
• Manufacturer Address: 1820 2ND AVENUE NORTH LAKE WORTH FL 33461 US 33461

Device Sequence Number: 3

• Brand Name: MAVIDON
• Generic Name: ADHESIVE REMOVER, MEDICAL
• Product Code: GYB
• Date Received: 2012-02-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MAVIDON MEDICAL PRODUCTS
• Manufacturer Address: 1820 2ND AVENUE NORTH LAKE WORTH FL 33461 US 33461

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-02-22