MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-08-20 for QUICKMOVE manufactured by Handicare Ab.
[117704681]
Fda esg webtrader account was disabled, a new account was set up to submit mdr's and so the delay in submission.
Patient Sequence No: 1, Text Type: N, H10
[117704682]
Leg stud broke at groove/undercut, separating leg from frame tube. Threaded rod ball joint clips missing. Event occurred during patient transfer. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009481053-2018-00033 |
| MDR Report Key | 7799031 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-08-20 |
| Date Facility Aware | 2018-06-25 |
| Date Added to Maude | 2018-08-20 |
| 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. YI-QIN BU |
| Manufacturer Street | SWEDEN TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, STOCKHOLMS LAN |
| Manufacturer G1 | BRAKO D.O.O |
| Manufacturer Street | RASHTANSKI PAT 2 |
| Manufacturer City | VELES, 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 |
| Generic Name | FLOOR LIFT |
| Product Code | IKX |
| Date Received | 2018-08-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | SWEDEN TORSHAMNSGATAN 35 KISTA, STOCKHOLMS LAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |