MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-18 for QUICKMOVE SIT-TO-STAND manufactured by Handicare Ab.
[139182470]
A staff member was assisting a user to stand using quick move standing aid device. The user and device began to tilt. The staff member lowered the user to the ground. The device was removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009481053-2019-00012 |
| MDR Report Key | 8430008 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-18 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-02-04 |
| Date Facility Aware | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-03-18 |
| 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 | MS. NEGAR KLINGENSTIERNA |
| Manufacturer Street | TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, 16440 |
| Manufacturer Country | SW |
| Manufacturer Postal | 16440 |
| Manufacturer G1 | BRAKO D.O.O |
| Manufacturer Street | RASHTANSKI PAT 2 |
| Manufacturer City | VELES, 1400 |
| Manufacturer Country | MK |
| Manufacturer Postal Code | 1400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKMOVE SIT-TO-STAND |
| Generic Name | TRANSFER AID |
| Product Code | IKX |
| Date Received | 2019-03-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | TORSHAMNSGATAN 35 KISTA, 16440 SW 16440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |