MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-29 for BIS 186-0106 manufactured by Jabil Circuit(shanghai) Ltd.
[146462545]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146462546]
According to the reporter, after the procedure was completed, when the sensor was removed, burn-like symptom was seen that the patient's skin was whitish and swollen. After several hours of observation, the patient skin condition was not improved and the redness of the skin injury was not relieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2019-00375 |
| MDR Report Key | 8652509 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-05-09 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-05-29 |
| 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 | JABIL CIRCUIT(SHANGHAI) LTD |
| Manufacturer Street | NO 600 TIAN LIN RD |
| Manufacturer City | SHANGHAI 20023 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 20023 |
| 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 | 2019-05-29 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Device Expiration Date | 2014-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT(SHANGHAI) LTD |
| Manufacturer Address | NO 600 TIAN LIN RD SHANGHAI 20023 CN 20023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-29 |