MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for REF NSB- 105-L manufactured by Human Care Canada Inc..
[177812001]
Nursing was using sling on lift to get patient out of bed into chair. The sling is used on a lift device, the sling tore along the seam. This was reported on a medsun report last week. The device lot numbers and serial numbers are different from the previous report. There was no patient injury but there is potential for harm. Per rn note: patient was in lift, using human care sling, and sling ripped while patient suspended. Patient was appropriate for sling (met weight limits, etc). Nursing staff did not use sling as pull sheet--placed sling beneath patient by rolling patient side to side. Used sling appropriately. Patient was assisted down to chair with no harm to patient. Ripped sling was sequestered we are currently in the process of finding another vendor to supply slings for these lift devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670551 |
| MDR Report Key | 9670551 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-29 |
| Report Date | 2020-01-30 |
| Date Reported to FDA | 2020-01-30 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-05 |
| Catalog Number | REF NSB- 105-L |
| Lot Number | 549 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMAN CARE CANADA INC. |
| Manufacturer Address | 4902 NORTH AMERICAN DRIVE BUFFALO NY 14224 US 14224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |