MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-09 for MONO-FLO * manufactured by Kendall, A Division Of Tyco Healthcare Group.
[403939]
The foley drainage system with the urometer on the bag has a loose fitting where the clear tubing joins the white connector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 679908 |
| MDR Report Key | 679908 |
| Date Received | 2006-02-09 |
| Date of Report | 2006-02-09 |
| Date of Event | 2006-01-24 |
| Report Date | 2006-02-09 |
| Date Reported to FDA | 2006-02-09 |
| Date Added to Maude | 2006-03-01 |
| 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 | MONO-FLO |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2006-02-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669184 |
| Manufacturer | KENDALL, A DIVISION OF TYCO HEALTHCARE GROUP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-09 |