MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-23 for URO1SPSDB14 manufactured by Medline Industries Inc..
| Report Number | 1417592-2019-00112 |
| MDR Report Key | 8815862 |
| Report Source | USER FACILITY |
| Date Received | 2019-07-23 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-06-27 |
| Date Mfgr Received | 2019-06-27 |
| Date Added to Maude | 2019-07-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRAY,CATH,FOLEY,100%SILIC,14FR,10ML,W/DB |
| Product Code | OHR |
| Date Received | 2019-07-23 |
| Catalog Number | URO1SPSDB14 |
| Lot Number | 19DBJ868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-23 |