MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-12-10 for TEN20 CONDUCTIVE PASTE 10-20 manufactured by D.o. Weaver Co..
[3656493]
Pt called to request a copy of msds for nuprep and ten20. She stated that she recently suffered injuries during a recent long-term neurodiagnostic exam at the eeg lab at (b)(6). During the exam prep on (b)(6) 2012. Pt noticed the tech spray a solution called neutral quat disinfectant cleaner concentrate on the electrodes used for her exam. Afterward, pt's skin was prepped with nuprep skin prep gel. During this time, pt told the tech that she was scrubbing too hard. The exam proceeded and ten20 conductive paste was used inside the electrodes, pressed onto the skin, and collodion was used to further attach the electrodes. Finally, the pt's head was wrapped to hold everything in place. Pt spent several days in pain, and burning an ditching were reported by the pt to the eeg lab. Electrodes were removed on (b)(6) 2012, and the pt noted that collodion remover was used to assist in removing the electrodes. Pt stated that at this time the burning intensified. Pt believes that a combination of products and misuse caused her injuries. Pt stated that she had burns, blisters, and red swollen skin. Pt went to urgent care on (b)(6) 2012 and was given a topical cream. On (b)(6) 2012, pt visited pcp. Pcp told her, she had allergic dermatitis and referred her to a dermatologist. Pt visited dermatologist on (b)(6) 2012. Dermatologist prescribed a different topical cream.
Patient Sequence No: 1, Text Type: D, B5
[11043395]
Spoke with pt on (b)(4) 2012. She stated that her skin has begun to heal and had a follow up appt with dermatologist on (b)(6) 2012. Dermatologist diagnosed pt with irritant dermatitis. Pt still experiences discomfort at electrode sites, but believes it is getting better. Pt will follow up with us if her condition changes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00015 |
| MDR Report Key | 3232350 |
| Report Source | 04 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-09-14 |
| Date Mfgr Received | 2012-10-16 |
| Date Added to Maude | 2013-07-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NICHOLAS LEE |
| Manufacturer Street | 565-B NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER CO. |
| Manufacturer Street | 565-B NUCLA WAY |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | NEURODIAGNOSTIC CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2012-12-10 |
| Model Number | 10-20 |
| Catalog Number | 10-20 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER CO. |
| Manufacturer Address | 565-B NUCLA WAY AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |