MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-27 for ESOPHAGEAL/RECTAL TEMPERATURE PROBE * ES400-18 manufactured by Smiths Medical Asd, Inc..
[17729294]
User alleges during a procedure, the pt awoke from surgery and was coughing and gagging. Someone looked at the device and noticed that the temp probe was missing. Pt had to be re-sedated so they could retrieve probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221261-2008-00029 |
| MDR Report Key | 1074351 |
| Date Received | 2008-06-27 |
| Date of Report | 2008-06-02 |
| Date of Event | 2008-05-30 |
| Date Facility Aware | 2008-06-02 |
| Report Date | 2008-06-27 |
| Date Reported to FDA | 2008-06-27 |
| Date Reported to Mfgr | 2008-06-27 |
| Date Added to Maude | 2008-07-15 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL/RECTAL TEMPERATURE PROBE |
| Generic Name | 73BZT ESOPHAGEAL |
| Product Code | BZT |
| Date Received | 2008-06-27 |
| Returned To Mfg | 2008-06-09 |
| Model Number | * |
| Catalog Number | ES400-18 |
| Lot Number | 7815 |
| ID Number | * |
| Device Expiration Date | 2011-01-01 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1040554 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 160 WEYMOUTH ST. ROCKLAND MA 02370 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-27 |