MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for CARTRIDGE manufactured by Unk.
[91205087]
Pt stated that cartridge malfunctioned and pt was not able to give dosage. Prescriber and mfr are aware. Pt will continue on medication. Dose or amount: 100mcg, frequency: daily, route: subcutaneously. Dates of use: from (b)(6) 2016 to ongoing. Diagnosis or reason for use: hypoparathyroidism. Reported to (b)(6) by: pt/caregiver. Physician name: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073151 |
| MDR Report Key | 7002947 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-28 |
| Date Added to Maude | 2017-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CARTRIDGE |
| Generic Name | SYRINGE, CARTRIDGE |
| Product Code | EJI |
| Date Received | 2017-11-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-06 |