MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-05 for MONOFLO DRAINAGE BAG UNK manufactured by Kendall.
[484025]
Foley urine bag not emptied on patient; found bulging by physician on rounds. Concern about possible obstruction of flow. Patient cardiac catheterization procedure put on hold. 3100 ml emptied. No permanent injury noted in follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 734299 |
| MDR Report Key | 734299 |
| Date Received | 2006-06-05 |
| Date of Event | 2006-12-09 |
| Date Reported to FDA | 2006-06-05 |
| Date Added to Maude | 2006-07-17 |
| 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 | MONOFLO DRAINAGE BAG |
| Generic Name | BAG, FOLEY |
| Product Code | EYZ |
| Date Received | 2006-06-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 722170 |
| Manufacturer | KENDALL |
| Manufacturer Address | DIVISION OF TYCO HEALTHCARE GR 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-05 |