MAUDE Adverse Event Report: D.O. WEAVER AND COMPANY TEN20 CONDUCTIVE PASTE; ADHESIVE CONDUCTIVE ELECTRODE PASTE

Model Number 10-20

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hair Loss (1877)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided by complainant.Patient and complainant are more concerned with who is going to pay for the patient's visit to the dermatologist.No information received suggests that permanent damage will result from the hair loss.However, if we receive additional information, we will submit a follow-up report.Based on received information, it is likely that the patient's hair dye and hair extensions contributed to the hair loss.Ten20 is water soluble and should easily rinse out from the hair with warm water.

Event Description

Received phone call from manager of a sleep lab regarding a patient that experienced hair loss after a sleep study.Patient claims that after the study there was still some electrode paste stuck in her hair.Upon trying to remove it, she claims that the hair at the electrode sites fell out.We recommended that the patient see her doctor or a dermatologist.

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: ADHESIVE CONDUCTIVE ELECTRODE PASTE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora 80011 9319
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora 80011 9319
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora 80011-9319 ; 3033661804
• MDR Report Key: 8627960
• MDR Text Key: 145646996
• Report Number: 1718791-2019-00002
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883149A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/21/2019

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: No Information
• Device Model Number: 10-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR