MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-28 for GEBAUER'S ETHYL CHLORIDE MIST SPRAY 0386-0001-02 manufactured by Gebauer Co..
[18544010]
The pt was receiving dialysis and gebauer's ethyl chloride mist spray (lot 3068) was applied for pre-injection anesthesia. The pt reported burning, blistering, scabbing and discoloration after application of the product.
Patient Sequence No: 1, Text Type: D, B5
[18953364]
The complaint as reported identified that the pt felt a burning sensation immediately after the product was applied that resulted in blistering, scabbing and discoloration. These adverse events are typically associated with frostbite that could result from over-application of the device. The complainant, who did not speak to the pt directly was told the product was applied by a nurse for approx 5 seconds. A 5 second spray is within the ifu but if the skin had turned white prior to the 5 seconds, the spray should have been stopped per the directions for use. Also, although rare, the adverse event could be the result of an allergic reaction to ethyl chloride or urticaria. Gebauer was told the pt required medical attention but no info was provided as to wat interventions were taken. Multiple attempts were made to obtain the unit back as well as seek further info on the injury and the medical attention required but we were informed the product would not be returned and no further info was available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2015-00001 |
| MDR Report Key | 4736168 |
| Report Source | 05 |
| Date Received | 2015-04-28 |
| Date of Report | 2015-04-27 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-03-27 |
| Device Manufacturer Date | 2014-04-29 |
| Date Added to Maude | 2015-04-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY PAUKPVITS |
| Manufacturer Street | 4444 E. 153RD ST. |
| Manufacturer City | CLEVELAND OH 44128 |
| Manufacturer Country | US |
| Manufacturer Postal | 44128 |
| Manufacturer Phone | 2165813030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEBAUER'S ETHYL CHLORIDE MIST SPRAY |
| Generic Name | CAPOCOOLANT |
| Product Code | MLY |
| Date Received | 2015-04-28 |
| Model Number | 0386-0001-02 |
| Lot Number | 3068 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-04-28 |