MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-27 for SURGICAL CLIPPER, CHARGING BASE CAH4414 manufactured by Jiangsu Better Electric.
| Report Number | 1423537-2019-00328 |
| MDR Report Key | 8739378 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-06-04 |
| Date Facility Aware | 2019-06-04 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-06-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | JIANGSU BETTER ELECTRIC |
| Manufacturer Street | 11 HUI HAI RD. BIN HAI ZONE QI DONG |
| Manufacturer City | JIANG SU 226200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 226200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL CLIPPER, CHARGING BASE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2019-06-27 |
| Returned To Mfg | 2019-06-11 |
| Model Number | CAH4414 |
| Catalog Number | CAH4414 |
| Lot Number | 1424-2552 &1806-275 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU BETTER ELECTRIC |
| Manufacturer Address | 11 HUI HAI RD. BIN HAI ZONE, QI DONG JIANG SU 226200 CH 226200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-27 |