MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-22 for HUDSON POCKET PEAK, PEAK FLOW METER 1801 manufactured by Teleflex.
[18305873]
The event is reported as: the customer reports that the patient barely exhales into the device and the range indicator reads maximum (inaccurate reading). No report of a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[18399197]
The results of the investigation are incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00097 |
| MDR Report Key | 3249802 |
| Report Source | 06 |
| Date Received | 2013-07-22 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-06-24 |
| Date Mfgr Received | 2013-07-02 |
| Date Added to Maude | 2013-10-17 |
| 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, RN |
| Manufacturer Street | PO 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. |
| 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 POCKET PEAK, PEAK FLOW METER |
| Generic Name | PEAK FLOW METER |
| Product Code | BZG |
| Date Received | 2013-07-22 |
| Catalog Number | 1801 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2013-07-22 |