MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for INVACARE FULL BODY, MESH SLING, XXL R140 manufactured by New Prokin International Ltd.
| Report Number | 1531186-2020-00007 |
| MDR Report Key | 9764976 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-05 |
| Date Facility Aware | 2020-02-05 |
| Report Date | 2020-02-27 |
| Date Reported to FDA | 2020-02-27 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE FULL BODY, MESH SLING, XXL |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-27 |
| Model Number | R140 |
| Catalog Number | R140 |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW PROKIN INTERNATIONAL LTD |
| Manufacturer Address | NO.51 HUASHIXIA ST SHENCHONG VILLAGE ZHONGSHAN CITY, GUANGDONG 528437 CH 528437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |