MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; KNEE WALKER,FOUR WHEELED

Catalog Number MDS86000G3

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that while end-user was walking using the knee walker, the front left wheel popped off resulting in end-user falling onto left foot.Per report, the end-user required use of knee walker due to recent left ankle surgery.Reportedly, the end-user went to visit her physician for a routine follow-up and an x-ray to her left foot was done.The end-user was reportedly told that her fall "messed-up my surgery." the end-user stated that she was scheduled to have a surgery (b)(6) 2019.Due to the reported event and need for surgery, this medwatch is being filed.The sample was returned for evaluation and the complaint could not be confirmed.A root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the end-user of a knee walker requires re-surgery of left ankle.The end-user reportedly fell when the left front wheel popped off the knee walker.

• Type of Device: KNEE WALKER,FOUR WHEELED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8791113
• MDR Text Key: 151053627
• Report Number: 1417592-2019-00117
• Device Sequence Number: 1
• Product Code: ITJ
• 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,distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

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: MDS86000G3
• Device Lot Number: 86718040007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 66