MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for WALGREENS manufactured by Unk.
[71394028]
Customer was using steam inhaler one day and it popped. Was using it for a cold and so was using the vaporizing steam liquid with it. This is what the (b)(6) store employees told him to use with it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068745 |
| MDR Report Key | 6446322 |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-03-01 |
| Date Added to Maude | 2017-03-30 |
| 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 |
| 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 | WALGREENS |
| Generic Name | PERSONAL STEAM INHALER |
| Product Code | KCO |
| Date Received | 2017-03-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-03-28 |