MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-11-19 for UNSPECIFIED BIS PRODUCT manufactured by Celestica Electronics S Pte.
| Report Number | 2936999-2019-00954 |
| MDR Report Key | 9342170 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-11-03 |
| Date Added to Maude | 2019-11-19 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | CELESTICA ELECTRONICS S PTE |
| Manufacturer Street | NO. 6 SERANGOON NORTH AVENUE |
| Manufacturer City | SINGAPORE 554910 |
| Manufacturer Country | SG |
| Manufacturer Postal Code | 554910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED BIS PRODUCT |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2019-11-19 |
| Model Number | UNSPECIFIED BIS PRODUCT |
| Catalog Number | UNSPECIFIED BIS PRODUCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELESTICA ELECTRONICS S PTE |
| Manufacturer Address | NO. 6 SERANGOON NORTH AVENUE SINGAPORE 554910 SG 554910 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-19 |