MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-25 for MAXI MOVE KMCLUN manufactured by Arjohuntleigh Magog Inc..
[186831500]
Additional information will be provided upon investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10
[186831501]
The arjo representative was informed about the event related to maxi move device. It was reported that the resident was transferred from a chair to the bed. When the caregiver tried to tilt the resident to the sitting position the powered dps was not working. Due to this fact the caregiver decided to placed the resident back into the chair. During transferring the resident got twisted sideways in the sling and the caregiver got the power dps working again. The resident's leg got twisted resulting in the injury. Resident sustained a knee injury and fracture. The orthopedic surgeon applied a soft cast to immobilize the knee. This resident had osteopenia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2020-00018 |
| MDR Report Key | 9749442 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-31 |
| Device Manufacturer Date | 2012-11-19 |
| Date Added to Maude | 2020-02-25 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG J1X5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X5Y5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXI MOVE |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-25 |
| Model Number | KMCLUN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |