MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-22 for MEDLINE URINARY DRAINAGE BAG DYNN15206 * manufactured by Medline Industries, Inc..
[163123]
Curity foley drainage bag with dial clamped, leaked urine (large amount) from the closed clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017612 |
| MDR Report Key | 251190 |
| Date Received | 1999-11-22 |
| Date of Report | 1999-11-19 |
| Date of Event | 1999-11-03 |
| Date Added to Maude | 1999-11-29 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDLINE URINARY DRAINAGE BAG |
| Generic Name | FOLEY BAG WITH ANTI-REFLUX VALVE |
| Product Code | FCN |
| Date Received | 1999-11-22 |
| Model Number | DYNN15206 |
| Catalog Number | * |
| Lot Number | 9A3141 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243344 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 600604456 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-22 |