MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-24 for ET TUBE PROTECTOR WITH SAFETY 1 manufactured by South Medic.
[34748149]
A bite block that was secured to an et tube slid down the patient's throat and was causing pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058808 |
| MDR Report Key | 5335615 |
| Date Received | 2015-12-24 |
| Date of Report | 2015-12-24 |
| Date of Event | 2015-11-24 |
| Date Added to Maude | 2015-12-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ET TUBE PROTECTOR WITH SAFETY 1 |
| Generic Name | ET TUBE PROTECTOR WITH SAFETY 1 |
| Product Code | MNK |
| Date Received | 2015-12-24 |
| Lot Number | 041915 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTH MEDIC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-24 |