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 2019-01-04 for HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041 manufactured by Teleflex Medical.
[132091689]
(b)(4). Patient code chosen was based on the information provided in the report. A death was reported, however there was no report that the teleflex device involved caused or contributed. Per report the cause of death was pneumonia by the attending physician. Based on the event description, the nurse confirmed there was no problem with the device prior to the adverse event. The description of the tubing (torn and twisted 47cm from the mask) is not indicative of a manufacturing issue. Additional information was requested by teleflex. It was reported there was no additional information or photo available. A device history record review could not be conducted since the lot number was not provided. Other remarks: inspection of the device involved was not possible as the device sample or a photo was not provided. However, material from the production line was verified and no issues were found that can lead this customer complaint. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and through investigation and determine a root cause, it is necessary to evaluate the sample involved. Root cause is undetermined. If the device becomes available at a later date, this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[132091690]
Complaint reads: "it was reported that (b)(6) 2018, am 8:06 nurse confirmed the tubing was no problem and there was consciousness of the patient. After a few minutes, a patient condition changed suddenly. " (cont. ) (cont. )" and user confirmed the torn off tube. After 30 mins resuscitation was performed, however death of a patient was confirmed (am 8:55). It was not the user complaint, we received this report from the officer of (b)(6) police, mr. (b)(6). Police is searching this issue now. Below information is from the police. It seemed that too much painful, a patient was torn off the tubing of the mask by oneself. The tubing was disconnected (torn and twisted) 47 cm from the mask side. The cause of the death was pneumonia by attending physician. Police would like to know the strength of the tube. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00007 |
| MDR Report Key | 8217745 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2019-01-04 |
| 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 | 2019-01-04 |
| Catalog Number | 1041 |
| 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 | 1. Other | 2019-01-04 |