MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-18 for AQUASONIC GEL manufactured by .
[18844709]
I had an allergic reaction to aquasonic gel used for an emg. I was in the emergency room 3 times for the reaction from (b)(6) 2012. On (b)(6) 2012, i was hospitalized for a major allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028266 |
| MDR Report Key | 2887479 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-12-13 |
| Date Added to Maude | 2012-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | AQUASONIC GEL |
| Product Code | MJS |
| Date Received | 2012-12-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2012-12-18 |