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 2018-12-18 for HUDSON MASK,HIGH CONC,ELONG,ADULT 1007 manufactured by Teleflex Medical.
[130771742]
(b)(4). The device involved or a picture of the alleged defect, was not provided to the manufacturer for evaluation. It was reported as disposed of by the user facility. A device history record review could not be conducted since the lot number was not provided. 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. 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
[130771743]
Customer complaint alleges that the reservoir bag was not inflated during use on a patient. No patient harm reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00368 |
| MDR Report Key | 8174144 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-12-18 |
| 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,HIGH CONC,ELONG,ADULT |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-12-18 |
| Catalog Number | 1007 |
| Lot Number | UNKNOWN |
| 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 | 2018-12-18 |