MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for PROAIR HFA manufactured by Teva Pharmaceutical.
[96810774]
Reporter states that the proair pump was unable to deliver treatment as expected when a (her) child went into respiratory distress yesterday. According to reporter, she has used hundreds of this pump with almost similar malfunction which makes her think the product (pump) is of poor quality and of no good and as such should be taken off the market. Per reporter, fda needs to take immediate action against this manufacturer to prevent what her child experienced from happening to any other child.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074435 |
| MDR Report Key | 7171436 |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2018-01-04 |
| Date Added to Maude | 2018-01-08 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Brand Name | PROAIR HFA |
| Generic Name | PUMP |
| Product Code | KCO |
| Date Received | 2018-01-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-01-05 |