MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-03-06 for TEN20 CONDUCTIVE PASTE UNK manufactured by D.o. Weaver And Company.
[20796642]
Pt reported hair loss after a sleep study was conducted on her. Sleep study completed (b)(6) 2012, pt went to beautician on (b)(6) 2012 to get the remaining paste removed from her hair. According to the pt, everywhere there was paste, there was also hair loss.
Patient Sequence No: 1, Text Type: D, B5
[20965930]
Reporter has been out of the office for a few weeks and has been unable to give us additional info as to the current condition of the pt. We will continue to follow up with her, but as our 30-day filing deadline is approaching, we will simply have to report what we know at this time. It is not uncommon for a pt to have some hair loss after electrodes have been stuck to the scalp for an extended period of time. We also know that the pt is on a long list of medications, many of which are known to also cause hair loss. Most likely it is a combination of the electrode paste, the treatment her beautician does on her hair, and the medications that she is on which has contributed to her hair loss. Pt currently taking the following medications: estradiol, synthroid, metformin, lipitor, omeprazole, cymbalta, levemir subq, novolog flexpen, lamictal, meclizine, spironolactone, torsemide, aspirin, phenytoin, docusate sodium, albuterol, losartan, coreg, nitrostat, saphris.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00002 |
| MDR Report Key | 2489557 |
| Report Source | 04 |
| Date Received | 2012-03-06 |
| Date of Report | 2012-03-05 |
| Date of Event | 2012-02-03 |
| Date Mfgr Received | 2012-02-08 |
| Date Added to Maude | 2012-03-13 |
| 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 | NICHOLAS LEE |
| 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 | TEN20 PASTE |
| Product Code | GYB |
| Date Received | 2012-03-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-06 |