MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-21 for TEN20 CONDUCTIVE PASTE 10-20 manufactured by D.o. Weaver And Company.
[145646996]
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.
Patient Sequence No: 1, Text Type: N, H10
[145646998]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2019-00002 |
| MDR Report Key | 8627960 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal | 800119319 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 800119319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | ADHESIVE CONDUCTIVE ELECTRODE PASTE |
| Product Code | GYB |
| Date Received | 2019-05-21 |
| Model Number | 10-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY, UNIT B AURORA 800119319 US 800119319 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |