MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-21 for HUDSON MASK,HIGH CONC,ELONG,ADULT 1007 manufactured by Teleflex Medical.
[133865723]
(b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. A device history record review could not be conducted since no lot number was reported. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and thorough investigation and determine the source of defect reported, it is necessary to evaluate the sample involved. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[133865724]
Customer complaint alleges the device reservoir bag was not inflated during use on a patient. A new device was obtained for use. No patient harm was reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00011 |
| MDR Report Key | 8264289 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-21 |
| Date of Report | 2019-01-07 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-01-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 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 MASK,HIGH CONC,ELONG,ADULT |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2019-01-21 |
| Returned To Mfg | 2019-02-07 |
| Catalog Number | 1007 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-21 |