MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for URINARY LEG BAG manufactured by Hollister.
[61493215]
Leg bag leaks urine from interface where drainage valve is inserted to the bag. I destroyed bag 1 and replaced with bag 2. Bag 2 has the same problem. I only used a total of 3 bags. Bag ok; bag 2 defective. Bag 3 defective. Two thirds is poor quality to me!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066471 |
| MDR Report Key | 6141010 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-13 |
| Date Added to Maude | 2016-12-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URINARY LEG BAG |
| Generic Name | URINARY LEG BAG |
| Product Code | NNW |
| Date Received | 2016-11-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER |
| Manufacturer Address | HOLLISTER 9814 |
| Brand Name | URINARY LEG BAG |
| Generic Name | URINARY LEG BAG |
| Product Code | NNW |
| Date Received | 2016-11-30 |
| Lot Number | 6EO3C |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-30 |