MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-08 for GEBAUER'S ETHYL CHLORIDE MIST SPRAY manufactured by Gebauer Company.
[99362968]
Gebauer's ethyl chloride spray applied to patient's big toe to reduce pain with minor procedure. Electrical cautery then used, causing ignition of the product. Patient suffered first degree burn to toe. Gebauer's ethyl chloride spray does have small flame and statement of flammability on the label, although this was not noticed or known by the provider using the product. Therapy duration: 1 day. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075134 |
| MDR Report Key | 7251596 |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-12-30 |
| Date Added to Maude | 2018-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | GEBAUER'S ETHYL CHLORIDE MIST SPRAY |
| Generic Name | GEBAUER'S ETHYL CHLORIDE MIST SPRAY |
| Product Code | MLY |
| Date Received | 2018-02-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-08 |