MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-25 for BEDSIDE DRAINAGE BAG manufactured by Kendall Co..
[17964]
Urinary back up may have caused increased bun and cr, kidney infection (severe). Sediment clogged filter to drainage bag foley catheter irrigates freely and urine was evident in tubing so blockage was not suspected. Pt became symptomatic and when drainage set was changed, 800cc of retained urine came thru. Required iv hydration and antibiotic. Returned to baseline status in 1 week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26110 |
| MDR Report Key | 26110 |
| Date Received | 1995-09-25 |
| Date of Report | 1995-09-21 |
| Date of Event | 1995-09-12 |
| Date Facility Aware | 1995-09-12 |
| Report Date | 1995-09-21 |
| Date Added to Maude | 1995-09-28 |
| 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 |
| 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 | BEDSIDE DRAINAGE BAG |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 1995-09-25 |
| ID Number | 3564620, 4013064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26770 |
| Manufacturer | KENDALL CO. |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1995-09-25 |