MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for ENDOTRACHEAL TUBE manufactured by Covidien.
[184272270]
Pt intubated upon arrival to ed. Pt admitted and transferred to icu without issue. Pt required tube change due to blown balloon. Will submit medwatch. No harm to pt. Ett available. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093822 |
| MDR Report Key | 9848141 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-16 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| 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 | ENDOTRACHEAL TUBE |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-17 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |