MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-02 for URINARY LEG BAG * 9349 manufactured by Hollister Inc..
[5235263]
Patient received urinary drainage bag ("leg bag"). When connected the bag leaked. Bag was replaced with another bag from the same lot #. The new bag worked. No patient injury, but patient inconvenience. (family member had to come in to return bag and obtain another. )======================manufacturer response for urine drainage bag, hollister (per site reporter). ======================will call back within 24 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4370810 |
| MDR Report Key | 4370810 |
| Date Received | 2014-12-02 |
| Date of Report | 2014-12-02 |
| Date of Event | 2014-12-02 |
| Report Date | 2014-12-02 |
| Date Reported to FDA | 2014-12-02 |
| Date Reported to Mfgr | 2014-12-30 |
| Date Added to Maude | 2014-12-30 |
| 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 | URINARY LEG BAG |
| Generic Name | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE |
| Product Code | FAQ |
| Date Received | 2014-12-02 |
| Model Number | * |
| Catalog Number | 9349 |
| Lot Number | 4A158 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INC. |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-02 |