FDA Adverse Event
Other
Summary report: N
TEN20 CONDUCTIVE PASTE
MDR report key: 1901393
·
Received November 10, 2010
Report
- Report Number
- 1718791-2010-00007
- Event Type
- Other
- Date Received
- November 10, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 10, 2010
- Manufacturer
- D.O. WEAVER AND COMPANY
- Product Code
- GYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION AND CONCLUSION BY OPERATING FACILITY THAT THE PT HAD PRE-EXISTING CONDITION AND HAIR THINNESS NOT RELATED TO EEG PROCEDURE OR PRODUCTS USED. PT ON BLOOD PRESSURE MEDICATION THAT CAN CAUSE HAIR LOSS AND THINNING. ALSO, PT HAS TREATED HAIR WITH CHEMICALS WHICH MAY HAVE CONTRIBUTED TO GENERAL HAIR LOSS AND BALD SPOTS.
Description of Event or Problem · 1
PT CLAIMED THAT EEG PROCEDURE CAUSED HER TO LOSE HAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEN20 CONDUCTIVE PASTE | TOPICAL CONDUCTIVE EEG PASTE | GYB | D.O. WEAVER AND COMPANY | 10-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |