MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-12-16 for TEN20 CONDUCTIVE PASTE UNK manufactured by D.o. Weaver And Co..
[2502178]
Pt, elderly woman, had eeg test in (b)(6) 2011. She stated that ten20, as well as other products, were used. Pt remained in hospital for a few months, during which time, her hair was never washed. As such, the ten20 was stuck in her hair for a long time. Pt was advised to use collodion remover (a mavidon product) to assist in removing ten20 from hair. After further discussions with pt, she stated that something kept running down onto her face from the hair, which she assumed to be melting ten20. A doctor visited her for an unrelated condition, but gave her some cortisone cream for her scalp and face. This doctor advised her to see a dermatologist.
Patient Sequence No: 1, Text Type: D, B5
[9454633]
Eval and investigation by interview of pt. Most likely cause is the fact that the pt was unable to properly clean her hair after the eeg test. After months of poor hygiene, she has likely developed some sort of infection of the scalp. Pt stated that rather than mess with trying to get the hardened ten20 out of her hair, she is just going to let her hair continue to grow out, and then she will get her hair cut. It is possible that what she thought was melted ten20 running from her scalp down her face was actually pus caused from an infection. We will follow-up with pt after she has had a chance to see a dermatologist, which may be after the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2011-00007 |
| MDR Report Key | 2386361 |
| Report Source | 04 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-12-14 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-11-17 |
| Date Added to Maude | 2011-12-23 |
| 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 | 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 | 2011-12-16 |
| 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 CO. |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-16 |