MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for ALTERA HANDSET (NO COST) manufactured by Pari Respiratory Equipment, Inc..
[184522816]
Pt uses the altera device to administer her cayston medication 75 mg three times a day for 2 weeks on and 2 weeks off. Ndc for cayston is 61958-0901-01. Pt stated the machine broke that she uses to initiate her cayston. No add'l info. Pt did not report any adverse events, unk if she missed any doses, has the device on hand for investigation or if she had a backup. New device shipped 03/03/2020. Product lot number and expiration date unk. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093842 |
| MDR Report Key | 9853376 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-01 |
| Date of Event | 2020-01-01 |
| Date Added to Maude | 2020-03-19 |
| 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 (NO COST) |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-03-18 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT, INC. |
| Brand Name | GILEAD |
| Product Code | --- |
| Date Received | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |