MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-12 for PAIN EAST TOPICAL ANESTHETIC SKIN REFRIGERANT 0396-0008-04 manufactured by Gebauer Co..
[20739962]
A gebauer co. Sales rep was in-servicing a doctor's office and was demonstrating gebauer's pain ease topical anesthetic skin refrigerant. A (b)(6), female nurse experienced a seizure shortly after being sprayed topically for 2 to 3 seconds with pain ease. The seizures lasted approx 2 to 3 min. Cpr was performed and the nurse was hospitalized for 24 hrs. While in the emergency dept, the nurse had a second seizure. As reported, the nurse returned to work within a week and had no impairment.
Patient Sequence No: 1, Text Type: D, B5
[20911320]
Due to the serious nature of the adverse event, gebauer co is reporting the event to the fda, but does not believe it is likely that gebauer's pain ease caused or contributed to the adverse event. This conclusion is based on the following: no other similar complaints have been reported to gebauer since the introduction of the product in 2002; the two ingredients used in pain ease are commonly used halogenated hydrocarbons and the toxicity data has been reviewed by the u. S. Epa as well as the fda and no instances of seizures at dosing done at high concentrations and extended dosing periods (up to two yrs) have been reported. Toxicity studies were conducted for both inhalation and dermal routes of exposure; toxicity studies performed by gebauer on the products specific formulation were conducted and no reports of seizures were identified during product testing and the safety data was submitted during the 510 (k) process; the nurse reported that her physician had taken her off of trileptal (oxcarbacine) the week prior to the adverse event. The medication guide for trileptal identifies that seizures can occur when the medication is stopped; and the nurse experienced another seizure while at the emergency dept and there was no exposure to pain ease. Multiple seizures after stopping tirleptal is also identified in the medication guide for the drug as a possible side effect. Based on the safety testing conducted on the ingredients of gebauer's pain ease, the nurse's medical history, and being taken off trileptal shortly before the adverse event, it is unlikely that gebauer's pain ease caused or contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2011-00001 |
| MDR Report Key | 2230597 |
| Report Source | 07 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-09-11 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2010-12-29 |
| Date Added to Maude | 2011-09-02 |
| 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 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 | PAIN EAST TOPICAL ANESTHETIC SKIN REFRIGERANT |
| Generic Name | VAPOCOOLANT |
| Product Code | MLY |
| Date Received | 2011-08-12 |
| Model Number | 0396-0008-04 |
| Lot Number | 9758 |
| Device Expiration Date | 2012-12-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-08-12 |