MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for QVAR manufactured by Teva Pharmaceutical Industries Ltd..
[102881283]
Reporter stated that the delivery system of qvar is malfunctioning. As instructed, patient shakes the cannister and tries to push the plastic dispenser however there is no compression as a result no medication comes out. With such failure, the customer is concerned that someone who is having an asthma attack will not be able to get the treatment needed. The customer went on saying that there is a safety concern of this failure. The customer is saying that this has been an ongoing issue with him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075919 |
| MDR Report Key | 7348114 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-02-14 |
| Date Added to Maude | 2018-03-19 |
| 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 | PATIENT |
| 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 | QVAR |
| Generic Name | INHALER, NASAL |
| Product Code | KCO |
| Date Received | 2018-03-15 |
| Lot Number | 170270 |
| ID Number | NDC #: 59310-204-12 |
| Device Expiration Date | 2019-08-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICAL INDUSTRIES LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |