MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-21 for AZTEC UNK manufactured by Aztec Medical Products, Inc..
[127779]
Dr's pt's have been obtaining readings 100 pts lower than actual with multiple lots of this peak flow meter. This trend has been noticed with different lots for the last two months. In some cases pts were placed on medications needlessly due to false readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016160 |
| MDR Report Key | 220066 |
| Date Received | 1999-04-21 |
| Date of Report | 1999-04-21 |
| Date of Event | 1999-03-01 |
| Date Added to Maude | 1999-04-27 |
| 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 | 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 | AZTEC |
| Generic Name | PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 1999-04-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 213423 |
| Manufacturer | AZTEC MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 289 MAIN AVE. STERLING NJ 07980 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-21 |