MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for GEBAUER'S MEDIUM JET STREAM SPRAY, 103.5 ML manufactured by Gebauer Co..
[103433354]
Patient presented with right finger swelling from jamming finger. Subungual hematoma, provider used ethyl chloride, or "freezy spray" before the procedure. The spray was flammable, and the cautery ignited the chux underneath. Provider extinguished the flames, no harm to patient. The product is not clearly labeled and identifiable for risk of flammability. The product is gebauer's ethyl chloride, by the gebauer company. Dose or amount: 103. 5 ml. Frequency: prn. Route: topical. Dates of use: (b)(6) 2017. Diagnosis or reason for use: subungual hematoma of nailbed. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076102 |
| MDR Report Key | 7369578 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-22 |
| Date of Event | 2017-04-29 |
| Date Added to Maude | 2018-03-26 |
| 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 | GEBAUER'S MEDIUM JET STREAM SPRAY, 103.5 ML |
| Generic Name | REFRIGERANT |
| Product Code | MLY |
| Date Received | 2018-03-26 |
| Lot Number | 2156 |
| Device Expiration Date | 2019-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Brand Name | GEBAUER'S MEDIUM JET STREAM SPRAY, 103.5 ML |
| Generic Name | REFRIGERANT |
| Product Code | MLY |
| Date Received | 2018-03-26 |
| Lot Number | 2156 |
| Device Expiration Date | 2019-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER'S COMPANY |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |