MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-04-22 for DRAINAGE WITH REFLUX VALVE DYNC1674 * manufactured by Medline Industries, Inc..
[265091]
Reported urine in a drainage bag backed up, which could potentially lead to a urinary tract infection. There was no adverse effect on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2003-00017 |
| MDR Report Key | 456447 |
| Report Source | 05,07 |
| Date Received | 2003-04-22 |
| Date of Report | 2003-04-08 |
| Date of Event | 2002-09-28 |
| Date Mfgr Received | 2003-04-01 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2003-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | ANDREA HAFERKAMP |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE WITH REFLUX VALVE |
| Generic Name | URINE COLLECTOR |
| Product Code | EYZ |
| Date Received | 2003-04-22 |
| Model Number | DYNC1674 |
| Catalog Number | * |
| Lot Number | 042802A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 445436 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US |
| Baseline Brand Name | DRAINAGE BAG W/REFLUX VALVE |
| Baseline Generic Name | URINE COLLECTOR |
| Baseline Model No | DYNC1674 |
| Baseline Device Family | DN11 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-04-22 |