MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-02 for ESOPHAGEAL STETHOSCOPE ES 400-18 * manufactured by Smiths Medical Asd, Inc..
[18108995]
At the end of surgery case the crna was removing the esophageal stethoscope and noted the tip of the plastic sheath had separated. The detached piece was removed from the patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061697 |
| MDR Report Key | 1061697 |
| Date Received | 2008-06-02 |
| Date of Report | 2008-06-02 |
| Date of Event | 2008-05-30 |
| Report Date | 2008-06-02 |
| Date Reported to FDA | 2008-06-02 |
| Date Added to Maude | 2008-06-19 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL STETHOSCOPE |
| Generic Name | TEMPERATURE SENSOR, ESOPHAGEAL |
| Product Code | BZW |
| Date Received | 2008-06-02 |
| Model Number | ES 400-18 |
| Catalog Number | * |
| Lot Number | 7815 |
| ID Number | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1029384 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 160 WEYMOUTH ST. ROCKLAND MA 02370 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-02 |