MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-12-13 for HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT 1059 manufactured by Teleflex Medical.
[130329586]
(b)(4). The device involved was not returned by the customer for evaluation by the manufacturer. A picture was submitted by the customer with the complaint, however this picture is not clear enough in order to confirm this customer complaint. The device history record (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Customer complaint cannot be confirmed based only on the information provided. To perform a proper investigation and determine the source of alleged defect reported, it is necessary to evaluate the sample involved. Root cause cannot be determined. No corrective actions can be assigned. If the sample becomes available this report will be updated with the evaluation results. Teleflex will continue to monitor customer feedback for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
[130329587]
Customer complaint alleges during use on a patient the bag component "burst". No patient harm was reported. Patient condition reported as fine. (cont. ) it was reported "the doctor secured the bag with a knot so that oxygenation of the patient could continue. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00360 |
| MDR Report Key | 8159799 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2018-12-13 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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,NON-REBREATH W/SAFETY VENT,ELONGAT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2018-12-13 |
| Catalog Number | 1059 |
| Lot Number | 74H1700882 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |