MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WALKER,GUARDIAN,W/5IN WHEEL,ADULT

Catalog Number G30757W

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, her husband was walking when the rollator 'slid away from him' causing him to fall onto the tile.The customer reported this has happened twice in the past week, causing him to fall on his left side 'bruising and swelling' his 'left hip', and 'hurting his knee'.The customer reported he had an mri that showed 'he has a torn meniscus' and received a 'steroid shot' from the physician.The sample is available but has not been returned for evaluation.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, her husband was walking when the rollator 'slid away from him' causing him to fall onto the tile.

• Type of Device: WALKER,GUARDIAN,W/5IN WHEEL,ADULT
• 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: 15868793
• MDR Text Key: 304344596
• Report Number: 1417592-2022-00229
• 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: 11/28/2022

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: G30757W
• Device Lot Number: 18722040003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male