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 2019-01-15 for HUDSON MASK,HIGH CONC,ELONG,ADULT 1007 manufactured by Teleflex Medical.
[133071641]
(b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. 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, to confirm the alleged defect reported, and determine the root cause, it is necessary to evaluate the sample involved. Root cause in undetermined. No corrective actions can be assigned at this time. If the sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[133071642]
Customer complaint states "the reservoir bag was not inflated. Therefore, a new unit was opened instead. The user had pre-inflated the reservoir bag before placing the mask on the patient, and the oxygen flow was more than 6l per minute. " no patient harm was reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00006 |
| MDR Report Key | 8248231 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-15 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2019-01-15 |
| 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 |
| 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 | 2019-01-15 |
| Catalog Number | 1007 |
| Lot Number | UNKNOWN |
| 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 | 2019-01-15 |