MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-08-02 for TEN20 CONDUCTIVE PASTE 10-20-4T manufactured by D.o. Weaver And Co..
[2188295]
Pt reported hair loss at certain sites of the electrodes placed in the scalp area. The test was an overnight sleep study.
Patient Sequence No: 1, Text Type: D, B5
[9403027]
Eval and investigation by interview of lab. The pt had her first sleep study on (b)(6) and a 2nd study on (b)(6). No other pts reported any hair loss with this lot or any other lot at this diagnosis site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2011-00005 |
| MDR Report Key | 2210104 |
| Report Source | 99 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-08-02 |
| Date of Event | 2011-07-08 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2011-02-17 |
| Date Added to Maude | 2012-06-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID WEAVER |
| Manufacturer Street | 565 NUCLA WAY UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | TEN 20 CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2011-08-02 |
| Model Number | 10-20-4T |
| Catalog Number | 10-20-4T |
| Lot Number | 016 |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND CO. |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-02 |