MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for ETHYL CHLORIDE manufactured by Gebauer Company.
[131052588]
Gebauer's ethyl chloride spray was applied to pt's great toe. Electrical cautery was subsequently used, causing ignition. The provider was able to quickly smother flame, although pt suffered first degree burn on his toe and is now undergoing wound care for this. The product label does have a small flame and warning of not using electrical cautery, however, the provider did not notice these warnings and or know about this risk. Date received 01/29/2018. Dosage form: spray. (b)(6). Access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082319 |
| MDR Report Key | 8185477 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date Added to Maude | 2018-12-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHYL CHLORIDE |
| Generic Name | REFRIGERANT, TOPICAL (VAPOCOOLANT) |
| Product Code | MLY |
| Date Received | 2018-12-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |