MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for UNK manufactured by Covidien.
[133227321]
During procedure start post intubation, oxygen saturations decreased briefly. Troubleshooting done, additional support given, and oxygen level returned throughout procedure. Upon extubation, the balloon on the endotracheal tube was malformed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8252517 |
| MDR Report Key | 8252517 |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-16 |
| Report Date | 2018-12-21 |
| Date Reported to FDA | 2018-12-21 |
| Date Reported to Mfgr | 2019-01-16 |
| Date Added to Maude | 2019-01-16 |
| 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 |
| Generic Name | CUFF, TRACHEAL, INFLATABLE |
| Product Code | BSK |
| Date Received | 2019-01-16 |
| Catalog Number | UNK |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |