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 |