MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-10-15 for HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041 manufactured by Teleflex Medical.
[125669343]
(b)(4). The device involved in this complaint has not been received for evaluation by the manufacturer 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 in this complaint. Customer complaint cannot be confirmed based only on the information provided. Root cause is unknown. No corrective actions can be assigned. If the sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[125669344]
Customer complaint alleges that during use on a patient, the tubing is loose and comes disconnected from the mask. No patient injury or complication was reported. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00297 |
| MDR Report Key | 7965196 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-10-15 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2018-10-15 |
| 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 |
| 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 | 2018-10-15 |
| Catalog Number | 1041 |
| Lot Number | 74F1800150 |
| 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 | 2018-10-15 |