MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-09-19 for PAIN EASE 0386-008-03 manufactured by Gebauer Co..
[4941659]
Pt had medical device (topical anesthetic skin refrigerant) applied to her arm prior to an iv start in preparation for a surgical procedure. After application of the device she experienced nasal tingling, coughing and chest heaviness. The hospital administered benadryl which alleviated her symptoms and after approximately 30 minutes the hospital performed surgical procedure as planned. Pt identified at the time of report she had no further symptoms. Pt had never been exposed to product previously.
Patient Sequence No: 1, Text Type: D, B5
[12208337]
The elevation of the complaint identifies that the pt most likely experienced an allergic reaction to the product or the aerosol delivery system of the product triggered an asthmatic reaction. These would not typically be considered serious illnesses but since medical intervention, benadryl, was provided to the pt, gebauer treats the adverse event as a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2014-00001 |
| MDR Report Key | 4117372 |
| Report Source | 04 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-18 |
| Date of Event | 2014-08-26 |
| Date Mfgr Received | 2014-08-26 |
| Date Added to Maude | 2014-09-26 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAIN EASE |
| Product Code | MLY |
| Date Received | 2014-09-19 |
| Model Number | 0386-008-03 |
| Catalog Number | 0386-008-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2014-09-19 |