MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-03-01 for HUDSON HIGH CONCENTRATION MASK, PEDIATRIC 1000 manufactured by Teleflex Medical.
[16748062]
The complaint was reported as: the reservoir bag did not inflate with the oxygen flow at 10l/m thus, the user increased the flow to 15l/mm yet is still did not inflate. Alleged defect discovered prior to patient use. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[16949374]
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report. A device history record (dhr) could not be conducted since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00062 |
| MDR Report Key | 2993009 |
| Report Source | 01,06,07 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-01-18 |
| Date Mfgr Received | 2013-02-07 |
| Date Added to Maude | 2013-05-09 |
| 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, SPECIALIST |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON HIGH CONCENTRATION MASK, PEDIATRIC |
| Generic Name | HIGH CONCENTRATION MASK |
| Product Code | BSJ |
| Date Received | 2013-03-01 |
| Returned To Mfg | 2013-02-20 |
| Catalog Number | 1000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-01 |