MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for ALTERA HANDSET manufactured by Pari Respiratory Equipment Inc..
[180633392]
Indication - cystic fibrosis, unspecified cystic fibrosis with pulmonary manifestations. Pseudomonas (aeruginosa), male (pseudomale) as the cause of disease classified elsewhere pt also stated that she needs a replacement altera device because the one she has is not working. Details are unk this prior to (b)(6) servicing pt. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093085 |
| MDR Report Key | 9729047 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-12 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Generic Name | NEBULIZER / DIRECT PATIENT INTERFACE |
| Product Code | CAF |
| Date Received | 2020-02-18 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT INC. |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |