MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-10 for MCKESSON CONSULT 120 URINE ANALYZER U120 manufactured by Acon Laboratories, Inc..
| Report Number | 2531491-2019-00002 |
| MDR Report Key | 8984947 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-10 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-06-18 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2019-09-10 |
| 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 | MR. QIYI XIE |
| Manufacturer Street | 10125 MESA RIM ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588758000 |
| Manufacturer G1 | ACON LABORATORIES, INC |
| Manufacturer Street | 10125 MESA RIM RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON CONSULT 120 URINE ANALYZER |
| Generic Name | URINE ANALYZER |
| Product Code | JRE |
| Date Received | 2019-09-10 |
| Returned To Mfg | 2019-07-05 |
| Model Number | U120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACON LABORATORIES, INC. |
| Manufacturer Address | 10125 MESA RIM ROAD SAN DIEGO, CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-10 |