MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-04-08 for HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL 1801 manufactured by Teleflex.
[4500380]
The complaint is reported as: the customer alleges that the peak flow meter is giving an inaccurate reading. Another device was used on the pt. The pt's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[11817745]
The device sample was not returned for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00114 |
| MDR Report Key | 3837830 |
| Report Source | 05,06,07 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-04-02 |
| Date Mfgr Received | 2014-04-03 |
| Date Added to Maude | 2014-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, REGULATORY AF |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL |
| Generic Name | PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 2014-04-08 |
| Catalog Number | 1801 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-08 |