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 2018-02-21 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.
[100777963]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100777964]
According to the reporter, the sensor caused damage/scratch to patient? S forehead. It was reported that when the sensor was removed, the forehead had some bleeding where the sensor had been placed. The customer indicated that there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00105 |
| MDR Report Key | 7286787 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-21 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-02-21 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Street | NO. 6 SERANGOON NORTH AVENUE 5 |
| 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 | BIS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2018-02-21 |
| Model Number | 186-0106 |
| Catalog Number | 186-0106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Address | NO. 6 SERANGOON NORTH AVENUE 5 SINGAPORE 554910 SG 554910 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |