MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for PROVENTIL HFA INHALATION AEROSOL WITH DOSE INDICATOR NDC 0085-1132-04 manufactured by Merck & Co., Inc. / Merck Sharp And Dohme Corp..
[122152066]
New instructions for a changed product are inadequate and could result in a disaster for some pts. Proventil hfa inhaler merck & co. : temperature limits in cleaning step 6 of the instructions suggests the medicine will be destroyed if carried at the high temperature possible in a normal pocket, over 25 c, 77 f. There is no instruction to avoid this or how higher temperatures would affect the effectiveness of the drug. Under "using your proventil hfa inhaler", figure d, the inhaler drawing does not show "mouthpiece fully into the mouth" as the drawing is from some other type of inhaler. It looks like the person is sticking their tongue into the inhaler. Totally wrong. They would die. There is no definition for "fev" in the "clinical trials: section making it impossible to judge the action of this drug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080157 |
| MDR Report Key | 7914302 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-09-25 |
| Date Added to Maude | 2018-09-27 |
| 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 | PROVENTIL HFA INHALATION AEROSOL WITH DOSE INDICATOR |
| Generic Name | NASAL INHALER |
| Product Code | KCO |
| Date Received | 2018-09-26 |
| Model Number | NDC 0085-1132-04 |
| Catalog Number | NDC 0085-1132-04 |
| Lot Number | 180340 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERCK & CO., INC. / MERCK SHARP AND DOHME CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-26 |