MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-24 for LIFESOUND 1520 18FR 10-1520-040 manufactured by Novamed.
[450012]
Female patient under general anesthesia underwent a procedure that required the use of an esophageal stethoscope and endotracheal tube. Some time after the procedure the patient complained of vague abdominal pain as her first symptom. Two weeks later the esophageal stethoscope was detected on a cat scan and was removed via an endoscope. Unknown to the staff, the stethoscope during this case was swallowed by the patient. It is suggested that the manufacturer reevaluate their current design to incorporate a means of preventing the patient from swallowing the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 691559 |
| MDR Report Key | 691559 |
| Date Received | 2006-02-24 |
| Date of Report | 2006-02-24 |
| Date of Event | 2005-10-01 |
| Report Date | 2006-02-24 |
| Date Reported to FDA | 2006-02-24 |
| Date Added to Maude | 2006-03-27 |
| 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 |
| 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 | LIFESOUND |
| Generic Name | STETHOSCOPE ESOPHOGEAL |
| Product Code | BZW |
| Date Received | 2006-02-24 |
| Model Number | 1520 18FR |
| Catalog Number | 10-1520-040 |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680696 |
| Manufacturer | NOVAMED |
| Manufacturer Address | 4 NURSERY LANE RYE NY 10580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-24 |