MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for ROLLATOR SFT SEAT BERGUNDY ZCHMT25BG manufactured by Aikin Healthcare Co., Lt.
| Report Number | 1423537-2019-00366 |
| MDR Report Key | 9239269 |
| Date Received | 2019-10-25 |
| Date of Report | 2019-10-25 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2019-10-14 |
| Date Added to Maude | 2019-10-25 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | AIKIN HEALTHCARE CO., LTD |
| Manufacturer Street | 178 KANG ZHUANG RD. ZHOU SHI ZHEN |
| Manufacturer City | KUNSHAN JIANGSU 215314 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215314 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROLLATOR SFT SEAT BERGUNDY |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2019-10-25 |
| Model Number | ZCHMT25BG |
| Catalog Number | ZCHMT25BG |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIKIN HEALTHCARE CO., LT |
| Manufacturer Address | 178 KANG ZHUANG RD. ZHOU SHI ZHEN KUNSHAN JIANGSU 215314 CH 215314 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-25 |