MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-10 for PROVENTIL HFA 6.7G - 200 METERED INHALATIONS manufactured by Schering Corp., A Subsidiary Of Schering Plough.
[1651504]
Pt using proventil hfa ndc 0085-132-01, lot 100299, exp 06/2012. Returned to the pulmonary clinic and stated that it is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018233 |
| MDR Report Key | 1902961 |
| Date Received | 2010-11-10 |
| Date of Report | 2010-11-10 |
| Date of Event | 2010-11-10 |
| Date Added to Maude | 2010-11-24 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVENTIL HFA 6.7G - 200 METERED INHALATIONS |
| Generic Name | ALBUTEROL SULFATE INHALATION AEROSOL |
| Product Code | KCO |
| Date Received | 2010-11-10 |
| Lot Number | 100299 |
| ID Number | 0085-1132-01 |
| Device Expiration Date | 2012-06-30 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHERING CORP., A SUBSIDIARY OF SCHERING PLOUGH |
| Manufacturer Address | KENILWORTH NJ 07033 US 07033 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-10 |