MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for ALTERA++ HANDSET manufactured by Pari Respiratory Equipment, Inc..
[173746370]
Pt's mother, (b)(6), reported the nebulizer was working when the cayston was ordered, but it has stopped working. Lot number and expiration date are unk. Unk if pt experienced an adverse event due to the defective product. Spontaneous call. No add'l info. Indication cystic fibrosis. Unspecified, situs inversus, pneumonia due to pseudomonas. Other disorders of lung, and other specified congenital malformations of respiratory system. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092017 |
| MDR Report Key | 9543879 |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-26 |
| Date Added to Maude | 2020-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | ALTERA++ HANDSET |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-01-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |