MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-10-21 for ETHYL CHLORIDE manufactured by Gebauer Co..
[90209]
Pt's mother dropped a bottle of ethyl chloride into a ceramic or stainless steel sink. It broke. Although the bottle is plastic coated, the coating stops under the threads so if neck breaks off the contents will escape. Apparently the neck broke off and the entire contents of the bottle hit the woman in the face and in particular one of her eyes. She claims her eyeball is red and blistered. An initial diagnosis is that the eye is chemically burned per one physician. This is an unlikely diagnosis, frostbite is more likely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519179-1997-00001 |
| MDR Report Key | 127219 |
| Report Source | 00 |
| Date Received | 1997-10-21 |
| Date of Report | 1997-10-21 |
| Date of Event | 1997-10-09 |
| Date Mfgr Received | 1997-10-09 |
| Date Added to Maude | 1997-10-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHYL CHLORIDE |
| Generic Name | SKIN REFRIGERANT |
| Product Code | MLY |
| Date Received | 1997-10-21 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 124490 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | 9410 ST. CATHERINE AVE. CLEVELAND OH 44104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-21 |