MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-09-26 for GABAUER'S ETHYL CHLORIDE manufactured by Gebauer Co..
[527384]
The patient was under the care of a physician and he ordered physical therapy and the use of gebauer's ethyl chloride to treat the patient's myofascial syndrome, which caused pain in the neck and shoulders. The physical therapist provided the patient with a bottle of gebauer's ethyl chloride during therapy session(s). The patient was found dead in their home. The medical examiner identifed the cause of death as chloroethane intoxication. Chloroethane is another name for ethyl chloride.
Patient Sequence No: 1, Text Type: D, B5
[7804616]
Gebauer's ethyl chloride is indicated for the treatment of myofascial pain and has been used for this indication since the 1950's, when dr janet travell developed and published the spray and stretch technique. This is the report of death related to use of gebauer's ethyl chloride in the lifetime of the product. Additionally, there are no complaints of any type regarding inhalation toxicity associated with gebauer's ethyl chloride. Inhalation toxicity regarding ethyl chloride is well published and documented. Inhalation toxicities have been reported in the medical literature when ethyl chloride was used as a general anesthetic. There are two published inhalation deaths due to ethyl chloride on pubmed (indexed for medline). Both indicate purposeful inhalation of ethyl chloride. The source of ethyl chloride for one complaint was a vcr head cleaner, the other is unknown. The precaution section of the gebauer's ethyl chloride labeling identifies that, "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. " additionally, the instructions for use for the spray and stretch technique for myofascial pain identify in section b. , spraying, "take precautions to cover the patient's eyes, nose and mouth if spraying near the face. " it does not appear that the product malfunctioned based on the documents provided to gebauer company and we were unable to have the bottle returned to us for investigation due to the time period between when the complaint occurred and when we became informed of the adverse event (approximately two years). Normal and appropriate use of the product would not cause inhalation toxicity or death. When gebauer's ethyl chloride is used as intended, the inhalation exposure is below osha/guidelines and is well below published toxicity data for toxic effects. A study was performed by the ohio bureau of workers compensation that evaluated end user exposure levels to gebauer's ethyl chloride products. The study indicated that it takes approximately 20 minutes to empty the contents of the product when sprayed at 5-second intervals. The concentration of ethyl chloride in the air was monitored, and the exposure level was found to be 260 ppm. The osha/gcgih short term exposure limit is 300/500 respectively. To empty an entire bottle of ethyl chloride in a twenty minute period represents a worst -case scenario, since most practitioners apply the product for a short period (less than a minute) and stretch the muscles. This activity may be repeated several times but you could certainly not spray the head and neck for 20 minutes without seeing other adverse effects like frostbite from extensive and repeated spraying. Even if the product had a serious malfunction, such as a catastrophic leak, it would still take at least one day for the entire contents of the bottle to revert to a gas form and evaporate into the air and the concentration of ethyl chloride vapors would be lower than 260 ppm. Also, the design and use of the gebaur's ethyl chloride bottle further supports that this type of inhalation toxicity would by highly unlikely to improbable under normal conditions of use. The bottle has a clamp mechanism that must be completely depressed to dispense the product from the bottle and the bottle must be held in an inverted position while the clamp is depressed. As described in the occupational health and safety guideline for ethyl chloride, health hazards section, the signs and symptoms of ethyl chloride toxicity increases as the concentration and length of time of exposure increases. The first signs of ethyl chloride inhalation toxicity in humans are dizziness, headaches, loss of concentration, nausea, vomiting, and at increasing concentrations and/or increasing durations of exposures depression of respiration, stupor, coma etc. At the onset of ethyl chloride inhalation toxicity (dizziness, nausea, loss of concentration), it would be unlikely that a patient could depress the gebauer's ethyl chloride clamp and hold the bottle inverted and continue spraying the product to the extent that inhalation toxicities resulting in death would be achieved. These facts make it unlikely that the death could have occurred through normal and expected operation of the product. Based on gebauer's investigation of this complaint, an mdr is warranted in that the device may have caused or contributed to the event but most likely occurred as a result of user error. At this time gebauer company does not believe any additional corrective action regarding this event is required for the following reasons: this is the only complaint of this type for the product. No other complaints or similar complaints have been received. We believe that the risk that the problem could cause a potentially hazardous event is remote since normal use of the product does not generate inhalation toxicity exposure levels that could cause death or serious injury. The product contains adequate labeling regarding inhalation toxicity. The device design is proper and adequate. The event is most likely the result of user error. Normal use of the product would not expose the patient to toxic inhalation exposure levels resulting in death or serious injury. The user error did not arise because the device failed to bear adequate directions for use or adequate warnings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2006-00001 |
| MDR Report Key | 766353 |
| Report Source | 04 |
| Date Received | 2006-09-26 |
| Date of Report | 2006-08-25 |
| Date of Event | 2004-03-24 |
| Date Mfgr Received | 2006-08-24 |
| Date Added to Maude | 2006-10-04 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AMY PAUKOVITS |
| Manufacturer Street | 4444 E. 153RD STREET |
| Manufacturer City | CLEVELAND OH 44128 |
| Manufacturer Country | US |
| Manufacturer Postal | 44128 |
| Manufacturer Phone | 2165813030 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GABAUER'S ETHYL CHLORIDE |
| Generic Name | SKIN REFRIGERANT / VAPOCOOLANT |
| Product Code | MLY |
| Date Received | 2006-09-26 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | 0386-0001-04/03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 754235 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | * CLEVELAND OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-09-26 |