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 2017-11-22 for MASK,NON-REBREATH W/O SAFETY VENT,ELONGA 1060 manufactured by Teleflex Medical.
[93453531]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report. The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine the root cause, it is necessary to evaluate the sample involved on this complaint. If the device sample becomes available at a later date this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[93453532]
Customer complaint alleges "when the user started using the mask on the patient, the bag did not inflate. Therefore, a new unit was used instead. " there was no injury or patient consequence reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00414 |
| MDR Report Key | 7053720 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2017-11-22 |
| 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 | MASK,NON-REBREATH W/O SAFETY VENT,ELONGA |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2017-11-22 |
| Returned To Mfg | 2017-12-14 |
| Catalog Number | 1060 |
| Lot Number | 74C1702557 |
| 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 | 2017-11-22 |