MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for MDS86222BRZ manufactured by Medline Industries Inc..
[145772391]
Reportedly, the end-user has caught the quad cane in revolving doors in the past and the device typically leans to the side. On the date of the incident, the quad cane "twisted completely" as the end-user was walking and she experienced a fall. The end-user was able to get herself back up after the fall and she went to her local hospital's emergency department (ed). Unidentified diagnostic exams were performed and the end-user stated that she was told that she did not experience a fracture. No ed medical treatments were reported to the manufacturer. The end-user was discharged home from the ed and followed up with a specialist who prescribed her physical therapy. No sample was returned to the manufacturer for evaluation. A root cause for the reported incident could not be determine. Due to the need for follow-up medical care, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145772392]
It was reported that the end-user experienced a fall and was required to have physical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00049 |
| MDR Report Key | 8550943 |
| Date Received | 2019-04-25 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-25 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CANE, QUAD, SMALL BASE, BRONZE |
| Product Code | IPS |
| Date Received | 2019-04-25 |
| Catalog Number | MDS86222BRZ |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-25 |