MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-26 for MAX-AIR AUTOHALER 400 manufactured by 3m Co..
[20897183]
Device is activated by pt's breathing. Device does not activate properly. Dr is aware of problems with this device through personal experience and pt complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000445 |
| MDR Report Key | 15009 |
| Date Received | 1994-07-26 |
| Date of Report | 1994-02-16 |
| Date Added to Maude | 1994-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAX-AIR AUTOHALER |
| Product Code | KCO |
| Date Received | 1994-07-26 |
| Model Number | 400 |
| Lot Number | 930703 |
| Device Expiration Date | 1996-04-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15003 |
| Manufacturer | 3M CO. |
| Manufacturer Address | ST PAUL MN 551441000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-26 |