MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for CURAPLEX manufactured by Bound Tree Medical, Llc.
[184272290]
A nasopharyngeal airway was found in a patient and the airway does not have any identifying information. It is a green soft plastic looking tube with 28fr on the side and small circle. According to the pictures of the curaplex by bound tree nasopharyngeal airway, it is similar in appearance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859916 |
| MDR Report Key | 9859916 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-05 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURAPLEX |
| Generic Name | NASOPHARYNGEAL AIRWAYS |
| Product Code | BTQ |
| Date Received | 2020-03-20 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOUND TREE MEDICAL, LLC |
| Manufacturer Address | 1420 LAKESIDE PARKWAY SUITE 105 FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |