MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for SELECT SILICONE URO180818 manufactured by Medline Industries, Inc..
[139626489]
After foley was achieved, it was found that the blue port on the urometer was broken off. Had to be removed. Urinary retention, chronic resp failure with hypoxia in acute distress with mass and mucous plugging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085075 |
| MDR Report Key | 8444023 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-12 |
| Date Added to Maude | 2019-03-22 |
| 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 | 3 |
| Brand Name | SELECT SILICONE |
| Generic Name | CATHETER, RETENTION TYPE, BALLOON |
| Product Code | EZL |
| Date Received | 2019-03-21 |
| Model Number | URO180818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Brand Name | VENTED URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL DISPOSABLE |
| Product Code | FFG |
| Date Received | 2019-03-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-03-21 |