MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-05 for SUMAVEL DOSEPRO manufactured by Zogenix.
[18914086]
Following use of sumavel dosepro i had slight echo problem in the right ear. I again used the sumavel on wednesday, (b)(6). Several hours later i lost the hearing in my right ear. I read the info sheet on the medication and it indicated there were ear problems in the trials. The doctor has told me i have total loss of hearing and can see no reasons why. Could you give me additional info regarding the loss of hearing during the trial usage? Dose or amount: one dose, once a day, as needed. Dates of use: #1: (b)(6) 2010; #2: (b)(6) 2010. Diagnosis or reason for use: migraine headaches. Sumavel dosepro used two doses (b)(6), (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016626 |
| MDR Report Key | 1750179 |
| Date Received | 2010-07-05 |
| Date of Report | 2010-07-05 |
| Date of Event | 2010-06-20 |
| Date Added to Maude | 2010-07-15 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Brand Name | SUMAVEL DOSEPRO |
| Generic Name | 6MG/ 0.5-ML NEEDLE-FREE DELIVERY SYSTEM |
| Product Code | KZE |
| Date Received | 2010-07-05 |
| Lot Number | 109381 |
| Device Expiration Date | 2010-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOGENIX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-05 |