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 2018-10-24 for HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041 manufactured by Teleflex Medical.
[124971971]
(b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. However material from the production line was verified and no issues were found that can lead this customer complaint. The device history record of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. To perform a proper investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved. Customer complaint cannot be confirmed based only on the information provided. Root cause is unknown. No corrective actions can be assigned. If the device becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[124971972]
Customer complaint alleges "the tubing comes off from the mask very easily. " alleged issue reported occurred during use. It was reported there were no consequences for the patient. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00321 |
| MDR Report Key | 8001439 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2018-05-11 |
| Date Added to Maude | 2018-10-24 |
| 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,MEDIUM CONC,ELONG,ADULT |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-10-24 |
| Catalog Number | 1041 |
| Lot Number | 74E1801729 |
| Device Availability | Y |
| 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 | 2018-10-24 |