MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-02 for BIS 186-0106 manufactured by Jabil Circuit(shanghai) Ltd.
| Report Number | 2936999-2019-00626 |
| MDR Report Key | 8953420 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-02 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-09-02 |
| 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 Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | JABIL CIRCUIT(SHANGHAI) LTD |
| Manufacturer Street | NO 600 TIAN LIN ROAD |
| Manufacturer City | SHANGHAI,20 200233 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 200233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2019-09-02 |
| Returned To Mfg | 2019-08-12 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Lot Number | 0508191L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT(SHANGHAI) LTD |
| Manufacturer Address | NO 600 TIAN LIN ROAD SHANGHAI,20 200233 CN 200233 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-02 |