MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-08 for DEVICE 1: TEN20 CONDUCTIVE PASTE 10-20-X manufactured by D.o. Weaver And Company.
[2723165]
Elderly female pt had a severe allergic reaction during a sleep study. Pt had swollen sites where electrodes were placed and her face was swollen including the inside of her mouth and the uvula to the point that she experienced difficulty breathing. As a result of her reaction, pt hospitalized for five days. Pt had a nuclear medicine study done prior to this event. During this study, nuprep was used to prep the skin. Pt had a mild skin reaction. During the sleep study, ten20 was certainly used, and possibly nuprep. Electrodes remained in place overnight. During this study, her reaction was much more severe than during the (b)(4) study.
Patient Sequence No: 1, Text Type: D, B5
[9845949]
Pt obviously has sensitive skin. We recommended that the pt be evaluated by an allergy specialist to determine what specific ingredients she is allergic to. The only ingredients common to both products are: 1, 2 - propanediol; methylparaben; propylparaben. All three common ingredients have been known to cause skin irritation with a small percentage of the population.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00007 |
| MDR Report Key | 2574138 |
| Report Source | 05 |
| Date Received | 2012-05-08 |
| Date of Report | 2012-05-07 |
| Date of Event | 2012-04-02 |
| Date Mfgr Received | 2012-04-11 |
| Date Added to Maude | 2012-05-16 |
| 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 | DEVICE 1: TEN20 CONDUCTIVE PASTE |
| Generic Name | ELECTROCONDUCTIVE MEDIA |
| Product Code | GYB |
| Date Received | 2012-05-08 |
| Model Number | 10-20-X |
| Catalog Number | 10-20-X |
| 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 COMPANY |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-08 |