MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; KNEE WALKER,WEIL,GEN 2

Catalog Number MDS86000G2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2022 they were using a rental scooter from drugmart due to a broken ankle, and when they went to use the scooter after getting out of bed the device tipped and he fell to the ground.Per the customer the family was able to assist in getting him up after the fall and brought him to the emergency room two days later on (b)(6) 2022.While in the emergency room the patient received, 'a shot of toradol and a lidocaine patch, and was instructed to take tylenol at home for pain control'.The sample was returned for evaluation and a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer on (b)(6) 2022 they were using a rental scooter from drugmart due to a broken ankle, and when they went to use the scooter after getting out of bed the device tipped and he fell to the ground.

• Type of Device: KNEE WALKER,WEIL,GEN 2
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15814958
• MDR Text Key: 303819185
• Report Number: 1417592-2022-00220
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86000G2
• Device Lot Number: 73616090002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention