MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-13 for VITAL SIGNS * manufactured by Vital Signs.
[18967956]
Pt reported to md that she passed protective end of esophageal stethoscope 1 1/2 months post surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037727 |
| MDR Report Key | 665964 |
| Date Received | 2006-01-13 |
| Date of Report | 2006-01-10 |
| Date of Event | 2005-11-19 |
| Date Added to Maude | 2006-01-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZW |
| Date Received | 2006-01-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SERIES 400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 655334 |
| Manufacturer | VITAL SIGNS |
| Manufacturer Address | 20 CAMPUS RD POTOWA NJ 07512 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-13 |