MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for PROAIR HFA manufactured by Ivax Pharmaceutical / Teva Pharmaceutical.
[119039385]
Reporter stated that nine months ago, his dr prescribed inhaler for his asthma attack. However, the medication he received was different from what his dr prescribed. He was having pain, fever, became lethargic, getting slower and slower. He said he could not figure out why he was feeling this way. He stopped the medication 2 days ago, and his pain subsiding. He believed that the medication is contaminated for him to have these kind of allergic reaction. He also thinks they are selling the medication at a discount rate because it is contaminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079516 |
| MDR Report Key | 7837150 |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-30 |
| Date Added to Maude | 2018-08-31 |
| 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 | 0 |
| Brand Name | PROAIR HFA |
| Generic Name | INHALER, NASAL |
| Product Code | KCO |
| Date Received | 2018-08-30 |
| Device Expiration Date | 2019-08-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVAX PHARMACEUTICAL / TEVA PHARMACEUTICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-30 |