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

Catalog Number MDS86228

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994); Inadequate Pain Relief (2388)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the quad cane "snapped" as the end-user was leaning forward while holding on to the device.The end-user experienced a right sided fall onto carpeted flooring.As the end-user fell he reportedly hit his right hip on a coffee table and "gashed" his knee and back on an entryway table.He was assisted back up by a family member.The end-user experienced soreness and pain "all over" and reported difficulty sitting down on his right buttock.Following an unspecified period of time after the fall incident, the end-user reportedly went to see his primary care physician and he was prescribed percocet for pain control.No diagnostic exams/results or medical interventions were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for prescription medication, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the quad cane "snapped" and the end-user experienced a fall.

• Type of Device: CANE, QUAD, LARGE 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: 9346840
• MDR Text Key: 189881261
• Report Number: 1417592-2019-00198
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86228
• Device Lot Number: 15117120003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 82