MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-05 for ASSESS STANDARD RANGE PEAK FLOW METER manufactured by Fisons Corp..
[19826]
A pt had been using this device for several months, but felt that it was not giving accurate readings. She purchased a different brand & got better readings. The reporter suggested that she take the flow meter to her physician. Her physician confirmed that the device was not giving accurate measurements of her breathing function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000805 |
| MDR Report Key | 26990 |
| Date Received | 1995-10-05 |
| Date of Report | 1995-08-21 |
| Date Added to Maude | 1995-10-13 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSESS STANDARD RANGE PEAK FLOW METER |
| Generic Name | METER |
| Product Code | BZH |
| Date Received | 1995-10-05 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27781 |
| Manufacturer | FISONS CORP. |
| Manufacturer Address | ROCHESTER NY 14603 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-10-05 |