MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for ETHYL CHLORIDE SPRAY TOPICAL ANESTHETIC BOTTLE 3.5 FL. OZ manufactured by Gebauer Company.
[35245987]
Patient presented to clinic for a steroid injection into a joint. The physician was preparing to apply ethyl chloride to the skin site. She heard a faint hissing sound and then the top piece of the ethyl chloride bottle (the small black piece that is attached to the metal spray trigger) dislocated from the larger black screw top piece of the bottle. The piece shot into the air and hit the patient on the forehead. The patient was not injured. Patient counseling provided: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058987 |
| MDR Report Key | 5350376 |
| Date Received | 2016-01-05 |
| Date Added to Maude | 2016-01-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 SPRAY TOPICAL ANESTHETIC BOTTLE 3.5 FL. OZ |
| Generic Name | ETHYL CHLORIDE SPRAY TOPICAL ANESTHETIC BOTTLE 3.5 FL. OZ |
| Product Code | MLY |
| Date Received | 2016-01-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |