MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for PREMIUM URINARY DRAIN BAG WITH ANTI-REFLUX VALVE 1450VA manufactured by Lsl Industries, Inc..
[128410160]
The bag itself is leaking around the creases and got urine all over an rn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081571 |
| MDR Report Key | 8101681 |
| Date Received | 2018-11-23 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-11-10 |
| Date Added to Maude | 2018-11-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PREMIUM URINARY DRAIN BAG WITH ANTI-REFLUX VALVE |
| Generic Name | URINE DRAIN BAG FOLEY / URINARY DRAINAGE COLLECTION KIT |
| Product Code | FCN |
| Date Received | 2018-11-23 |
| Catalog Number | 1450VA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LSL INDUSTRIES, INC. |
| Manufacturer Address | CHICAGO IL US |
| Brand Name | PREMIUM URINARY DRAIN BAG WITH ANTI-REFLUX VALVE |
| Generic Name | URINE DRAIN BAG FILEY / URINARY DRAINAGE COLLECTION KIT |
| Product Code | PPG |
| Date Received | 2018-11-23 |
| Catalog Number | 1450VA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSL INDUSTRIES, INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-23 |