MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-13 for URINARY LEG BAG SYSTEM 9348 manufactured by Hollister Incorporated.
[3962732]
It was reported that an (b)(6) male with hematuria came to the er stating that his urine would not drain through the tubing to the leg bag. It was observed that the urine drainage tube was collapsed upon itself and not draining. The tubing was disconnected from the patient's indwelling catheter which was then hand irrigated to remove a blood clot. A new leg bag system was attached. The nurse manager stated that because the tubing did not allow the urine to drain from the bladder a clot formed and irrigation/evacuation was required. The irrigation resolved the problem and the patient went home.
Patient Sequence No: 1, Text Type: D, B5
[11324354]
The potential for blood clot formation in the bladder always exists for patients with hematuria as was reported in this case. The cause of the reported collapse of the urinary drainage tube is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1480288-2013-00008 |
| MDR Report Key | 3519458 |
| Report Source | 06 |
| Date Received | 2013-12-13 |
| Date of Report | 2013-12-13 |
| Date Facility Aware | 2013-09-17 |
| Report Date | 2013-11-14 |
| Date Reported to Mfgr | 2013-11-14 |
| Date Mfgr Received | 2013-11-14 |
| Date Added to Maude | 2013-12-16 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANNE RIBA |
| Manufacturer Street | 2000 HOLLISTER DR |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476805625 |
| Manufacturer G1 | HANGZHOU JINCHENG |
| Manufacturer Street | 202 ZHANGSHAN ROAD |
| Manufacturer City | YUHANG, HANGZHOU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY LEG BAG SYSTEM |
| Generic Name | URINARY LEG BAG SYSTEM |
| Product Code | NNW |
| Date Received | 2013-12-13 |
| Model Number | 9348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DR LIBERTYVILLE IL 60083 US 60083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-13 |