MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,08 report with the FDA on 2014-09-29 for HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA 1801 manufactured by Teleflex.
[4950267]
The event is reported as: the customer alleges that the device is indicating an inaccurate reading when used by the pt. No report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[12239035]
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00274 |
| MDR Report Key | 4132993 |
| Report Source | 04,05,06,08 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-08 |
| Date of Event | 2014-09-02 |
| Date Mfgr Received | 2014-09-08 |
| Date Added to Maude | 2014-10-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA |
| Generic Name | PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 2014-09-29 |
| Returned To Mfg | 2014-09-17 |
| Catalog Number | 1801 |
| Device Expiration Date | 2012-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-09-29 |