MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for MAXI SKY 2 manufactured by Arjohuntleigh Magog Inc..
[188484088]
It was reported that patient fell out of the device. Based on provided information it was possible that sling loop become detached from the device. As a consequence of the event patient sustained subdural hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2020-00017 |
| MDR Report Key | 9864364 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2020-03-23 |
| Date Reported to FDA | 2020-03-23 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Brand Name | MAXI SKY 2 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-03-23 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-23 |