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

Catalog Number MDS86222W

Device Problem Material Twisted/Bent (2981)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the shaft of the quad cane bent and the end-user experienced a fall.The end-user was assisted back up by a caregiver after the fall incident.The end-user stated that she experienced a left-sided rib fracture, however, denies going to a hospital emergency department or doctor's office.She stated that she is a retired athlete and "knows there's nothing you can do for fractured or cracked ribs." no diagnostic exams or medical intervention was reported.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined at this time.Due to the reported rib fracture, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the shaft of the quad cane bent and the end-user experienced a fall.

• Type of Device: CANE, QUAD, SMALL BASE, BLACK
• 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: 12298880
• MDR Text Key: 265763663
• Report Number: 1417592-2021-00124
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86222W
• Device Lot Number: J080931347
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/09/2021
• 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): Other; Disability
• Patient Weight: 61