MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-07-26 for F-DRAINBAG, LATEX FREE, 2000M DYND15205H * manufactured by Medline Industries, Inc..
[336335]
Reportedly, two pts contracted urinary tract infections while utilizing the drain bags. The pts were treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2004-00020 |
| MDR Report Key | 536164 |
| Report Source | 05,07 |
| Date Received | 2004-07-26 |
| Date of Report | 2004-07-21 |
| Date of Event | 2004-06-30 |
| Date Mfgr Received | 2004-06-30 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2004-07-28 |
| 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 | 3 |
| 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 | F-DRAINBAG, LATEX FREE, 2000M |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2004-07-26 |
| Model Number | DYND15205H |
| Catalog Number | * |
| Lot Number | 031504A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 525416 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US |
| Baseline Brand Name | F-DRAINBAG, LATEX FREE, 2000M |
| Baseline Generic Name | DRAINAGE BAG |
| Baseline Model No | DYND15205H |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-26 |