MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ALTERA HANDSET manufactured by Pari Respiratory Equipment, Inc..
[182565186]
Pt reported that altera device used to initiate cayston is not working properly (no specific details provided); this was the initial report to pharmacy. Lot number, expiration date, and pt identification number for program unk. Not specified if pt missed any doses or experienced an adverse event. Unk if the pt has the product on hand for return. Replacement has been scheduled, but has not shipped yet. Spontaneous cal, no add'l info available. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093557 |
| MDR Report Key | 9799910 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-19 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-05 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT, INC. |
| Brand Name | 75MG/VL |
| Product Code | --- |
| Date Received | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |