MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-15 for GABAUER'S FLURO-ETHYL 0386-0002-20 manufactured by Gebauer Co..
[21255060]
A unit of gebauer's fluro-ethyl malfunctioned and the skin refrigerant sprayed out from the side of the valve instead of spraying from the product's actuator. Fluro-ethyl is provided in an aerosol container and consists of a can, valve and actuator. The malfunctioning unit sprayed sideways as well as spraying in the normal inverted position. The product was intended to be sprayed on the pt's upper arm prior to an injection, but the malfunctioning spray contacted the pt's neck and ear. No injury was reported as a result of the malfunctioning unit. The product is intended to contact the skin and normal instructions for use, is to spray the product on the skin for 2 to 3 seconds for pre-injection anesthesia. Inadvertent spraying of the skin for 2 to 3 seconds would not cause an injury. If the malfunction were to reoccur, and the product inadvertently sprayed into the eyes there could be resulting injury. It is unlikely that short contact of the skin refrigerant with the eyes would result in a serious injury but it could possibly occur. Gebauer reviewed other complaints of inadvertent spraying in the eyes with functioning product and no serious injuries were reported. Injuries of spraying in the eyes is most likely to result in an injury that is temporary and reversible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519179-2008-00001 |
| MDR Report Key | 1150884 |
| Report Source | 05 |
| Date Received | 2008-08-15 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-07-14 |
| Date Mfgr Received | 2008-07-14 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2010-04-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4444 E. 153RD STREET |
| Manufacturer City | CLEVELAND OH 44128 |
| Manufacturer Country | US |
| Manufacturer Postal | 44128 |
| Manufacturer Phone | 2165813030 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GABAUER'S FLURO-ETHYL |
| Generic Name | FLURO-ETHYL |
| Product Code | MLY |
| Date Received | 2008-08-15 |
| Model Number | 0386-0002-20 |
| Catalog Number | 0386-0002-20 |
| Lot Number | 7010 |
| Device Expiration Date | 2009-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-08-15 |