MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-10-31 for GEBAUER'S ETHYL CHLORIDE 0386-0001-03 manufactured by Gebauer Co..
[2926987]
The adverse event as reported to gebauer company was hallucinations after exposure to gebauer's ethyl chloride medium bottle product. The patient had been prescribed gebauer's ethyl chloride for home treatment of tmj related pain. To treat the tmj pain, the patient opened a bottle of product by removing the spray nozzle and poured the product onto gauze pads and applied the ethyl chloride soaked pads to his face. The patient began to experience hallucinations and was admitted to the emergency department of approximately 2. 5 hours and then released when the hallucinations stopped.
Patient Sequence No: 1, Text Type: D, B5
[10361966]
The patient identified that he had been prescribed gebauer's ethyl chloride for home treatment of tmj related jaw pain. The product is not indicated for this use. The only treatment related to tmj is under the product's indication for the treatment of myofascial pain using the spray and stretch technique. Additionally, contrary to the instructions for use, the patient removed the spray nozzle and poured the product on gauze pads and applied the ethyl chloride soaked pads to his face. The instructions for use require that the product be sprayed in a specific manner followed by stretching. This does not include soaking gauze pads with the product and applying to the face/jaw. The use of the product was not in accordance with the intended use of the product or the product's instructions for use. The adverse event as reported to gebauer was hallucinations after exposure to the product. As stated on the product labeling, "inhalation of ethyl chloride should be avoided as it may produce narcotic and general anesthetic effects, deep anesthesia or fatal coma with respiratory or cardiac arrest. " it cannot be determined from the complaint if the patient inhaled the product inadvertently from the gauze soaked pads or if he was purposefully inhaling the product. To pour the product on gauze pads, the patient identified that he unscrewed the spray nozzle from the bottle. It should be noted that the nozzle is automatically torqued onto the bottle during the manufacturing process and can't be removed by hand and requires pliers and force to remove. The patient identified that the nozzle was loose and he removed it by hand. If the nozzle was loose, the patient would have received an empty bottle as ethyl chloride is a volatile gas which is only a liquid when compressed. The patient could only have removed the nozzle with significant force. The adverse event of hallucinations from inhalation of ethyl chloride was caused by using the product in a manner contrary to the product's intended use and instructions for use. The products labeling is adequate and identifies the risks associated with inhalation of the product. The risk of inhalation toxicity is low when the product is used correctly. There was no product malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2012-00002 |
| MDR Report Key | 2820097 |
| Report Source | 04 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-10-19 |
| Date Mfgr Received | 2012-10-19 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2012-11-07 |
| 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 PAUKOVITS |
| 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 |
| Generic Name | ETHYL CHLORIDE, VAPOCOOLANT |
| Product Code | MLY |
| Date Received | 2012-10-31 |
| Catalog Number | 0386-0001-03 |
| Lot Number | 2076 |
| Device Expiration Date | 2015-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Life Threatening | 2012-10-31 |