MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for STERIGEAR URINARY DRAIN BAG manufactured by Sterigear, Llc.
[78034111]
Collection chamber locked and not draining into indwelling catheter bag (negative pressure valve stuck and non - return valve closed. ) removed when pt admit to icu. Dates of use: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070513 |
| MDR Report Key | 6653104 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-05-06 |
| Date of Event | 2017-05-25 |
| Date Added to Maude | 2017-06-20 |
| 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 | STERIGEAR URINARY DRAIN BAG |
| Generic Name | FIG LEAF DRAIN BAG |
| Product Code | FCN |
| Date Received | 2017-06-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIGEAR, LLC |
| Manufacturer Address | PROVO UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |