MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for DIASTAT ACUDIAL manufactured by Unk.
[71530319]
Diastat was difficult to dial correct dose. The device locked at incorrect dose of 10 mg. The first device dialed with ease to be locked at 7. 5 mg. Will return to manufacturer when the correctly dialed dose is returned to be sent with the device locked with wrong dose. Patient will be given 2 corrected dialed diastat. Diastat acudial never used by patient yet, for emergency use. Dose or amount: 7. 5 mg. Frequency: prn. Route: rectal. Dates of use: 1 year. Diagnosis or reason for use: for seizure greater than 5 minutes. Is the product compounded: no. Is the product over-the-counter: no. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068809 |
| MDR Report Key | 6450739 |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-03-17 |
| Date Added to Maude | 2017-03-31 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIASTAT ACUDIAL |
| Generic Name | APPLICATOR FOR RECTAL SUPPOSITORY |
| Product Code | OOW |
| Date Received | 2017-03-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |