MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-12-10 for OOK SNOW FL36 manufactured by Umano Medical Inc.
[129828183]
User contacted service support for an integrated bed exit detection system allegedly not working properly. Patient "felt" with scratch on the scalp; no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009591865-2018-00021 |
| MDR Report Key | 8148109 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2018-06-26 |
| Date Added to Maude | 2018-12-10 |
| 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 | MS MAUDE THIBAULT |
| Manufacturer Street | 230 BOULEVARD NILUS-LECLERC |
| Manufacturer City | L'ISLET, QUEBEC |
| Manufacturer Country | CA |
| Manufacturer G1 | UMANO MEDICAL INC |
| Manufacturer Street | 230 BOULEVARD NILUS-LECLERC |
| Manufacturer City | L'ISLET, QUEBEC G0R 2C0 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | G0R 2C0 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OOK SNOW |
| Generic Name | MEDICAL BED |
| Product Code | FLN |
| Date Received | 2018-12-10 |
| Model Number | FL36 |
| Catalog Number | FL36 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMANO MEDICAL INC |
| Manufacturer Address | 230 BOULEVARD NILUS-LECLERC L'ISLET, QUEBEC G0R 2C0 CA G0R 2C0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-10 |