MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-21 for DYND44108 manufactured by Medline Industries Inc..
[177943712]
It was reported to the manufacturer via a medwatch filed by the end-user that an infant was choking on a delee mucus trap device. Per the reporter, an infant was in their room with their father and the father called out for assistance. Reportedly the nurse entered the room and noted that the infant was choking on the delee device. The nurse reported that the device was coiling in the back of the infant's throat. No additional details are available related to the customer reported issue. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product or incident details to the manufacturer. There was no medical intervention, follow up care or serious injury reported related to this event. The sample has not been returned to the manufacturer for evaluation. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177943713]
It was reported to the manufacturer via a medwatch filed by the end-user that an infant was choking on a delee mucus trap device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00237 |
| MDR Report Key | 9612839 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-21 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRAP,MUCUS,8FR,DELEE,W/VALVE |
| Product Code | BYZ |
| Date Received | 2020-01-21 |
| Catalog Number | DYND44108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-21 |