MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-09 for HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT 1059 manufactured by Teleflex Medical.
[104876015]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report. However material from the production line was verified and no issues were found that can lead to this customer complaint. The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. To perform a proper investigation to confirm the alleged defect and determine a root cause, it is necessary to evaluate the sample involved. If the device becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[104876016]
Customer complaint alleges "the mask works improperly. Leak found during use, at the level of the tube. " the device was changed for a new one. There was no report of patient impact or consequence. Patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00109 |
| MDR Report Key | 7407780 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-09 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2013-11-27 |
| Date Added to Maude | 2018-04-09 |
| 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 |
| 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,NON-REBREATH W/SAFETY VENT,ELONGAT |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2018-04-09 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | 1059 |
| Lot Number | 02L1302800 |
| 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 | 2018-04-09 |