MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-16 for SHWR COMMODE 5 IN CASTER 18 INW 9153640951 NA:6891 6891 manufactured by Jiangsu Yuyue Medical Equipment & Supply Co Ltd.
| Report Number | 1531186-2019-00005 |
| MDR Report Key | 8794161 |
| Date Received | 2019-07-16 |
| Date of Report | 2019-06-24 |
| Date Facility Aware | 2019-06-24 |
| Report Date | 2019-07-16 |
| Date Reported to FDA | 2019-07-16 |
| Date Reported to Mfgr | 2019-07-16 |
| Date Mfgr Received | 2019-07-16 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2019-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHWR COMMODE 5 IN CASTER 18 INW 9153640951 |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2019-07-16 |
| Model Number | NA:6891 |
| Catalog Number | 6891 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD |
| Manufacturer Address | YUNYANG INDUSTRIAL PARK DANYANG, CHINA CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-16 |