MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-03 for HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA 1801 manufactured by Teleflex.
[17259257]
The complaint is reported as: the customer (physician) alleges that the device was not measuring an accurate measurement while in use on a patient. The blue indicator was very loose. The device was changed out for another. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[17623735]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00163 |
| MDR Report Key | 3941880 |
| Report Source | 05 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-16 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-16 |
| Date Added to Maude | 2014-07-29 |
| 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 |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM 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 | POCKET PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 2014-06-03 |
| Catalog Number | 1801 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-06-03 |