MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CANE, QUAD, SMALL BASE, BRONZE

Catalog Number MDS86222BRZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the end-user experienced a fall and was required to have physical therapy.

• Type of Device: CANE, QUAD, SMALL BASE, BRONZE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8550943
• MDR Text Key: 145772391
• Report Number: 1417592-2019-00049
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86222BRZ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 76