MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for ALTERA HANDSET manufactured by Pari Respiratory Equipment Inc.
[184516081]
Inbound call from patient states she does not have a working altera device. The altera device is using to administer her cayston medication. Start of cayston is unknown because the patient was on prior to using (b)(6) speciality. Ndc for cayston = 61958-0901-01 unknown if patient missed doses, experienced an adverse event or if the device is available for retrieval. Reported to (b)(6) by patient/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093849 |
| MDR Report Key | 9859721 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-16 |
| Date Added to Maude | 2020-03-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTERA HANDSET |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-03-19 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT INC |
| Brand Name | ALTERA HANDSET (NO COST) GILEAD |
| Product Code | --- |
| Date Received | 2020-03-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |