MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-10-10 for HUDSON MASK,MEDIUM CONC,ELONG,PED 1042 manufactured by Teleflex Medical.
[123265353]
(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. 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. Root cause is unknown. No corrective actions can be assigned. If the device sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[123265354]
Customer complaint alleges device "tubing is coming apart at the mask connection". Alleged malfunction reported occurred during use. No patient injury or consequence reported. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00294 |
| MDR Report Key | 7952577 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-10-10 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-07-03 |
| Date Added to Maude | 2018-10-10 |
| 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 | 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,MEDIUM CONC,ELONG,PED |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-10-10 |
| Returned To Mfg | 2018-10-08 |
| Catalog Number | 1042 |
| Lot Number | 74G1800724 |
| 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 | 2018-10-10 |