MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-05 for BOUGIE 9-0212-70 manufactured by Sunmed.
[18790731]
Bougie introducer tube used for intubation. After was used in the patient's mouth, approx at the 27 cm mark there was a brown mark that corresponding to a brown mark in the sterile wrapper. The tube was placed in the patient's mouth to the 23 cm mark. No patient harm detected. Diagnosis or reason for use: endotracheal intubation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036489 |
| MDR Report Key | 3866663 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-12 |
| Date Added to Maude | 2014-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOUGIE |
| Generic Name | INTRODUCER FOR ADULT ENDOTRACHEAL INTUBATION |
| Product Code | FAX |
| Date Received | 2014-06-05 |
| Model Number | 9-0212-70 |
| Lot Number | MD058 |
| Device Expiration Date | 2015-09-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-05 |