MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-04 for BIS 186-0106 manufactured by Jabil Circuit Singapore Pte Ltd.
[177617960]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177617961]
According to the reporter, post operatively, the patient had a pressure sore on the forehead, and not recover after four days.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2936999-2020-00091 |
MDR Report Key | 9665089 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-02-04 |
Date of Report | 2020-02-04 |
Date of Event | 2020-01-17 |
Date Mfgr Received | 2020-01-22 |
Device Manufacturer Date | 2019-04-02 |
Date Added to Maude | 2020-02-04 |
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 SINGAPORE PTE LTD |
Manufacturer Street | 16 TAMPINES CRESCENT |
Manufacturer City | SINGAPORE 528604 |
Manufacturer Country | SG |
Manufacturer Postal Code | 528604 |
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 | 2020-02-04 |
Model Number | 186-0106 |
Catalog Number | 186-0106 |
Lot Number | 0402191K |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | JABIL CIRCUIT SINGAPORE PTE LTD |
Manufacturer Address | 16 TAMPINES CRESCENT SINGAPORE 528604 SG 528604 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-04 |