MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,STEEL,KNOCK-DOWN

Catalog Number MDS86850ESKD

Device Problems Defective Component (2292); Unintended Movement (3026)

Patient Problem Head Injury (1879)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that while ambulating with the walker the brakes did not engage when she tried to stop and the customer fell backwards resulting in the customer sustaining a cut to the back of her head and requiring two staples.The customer stated that the paramedics came to her home and took her to the hospital.After the evaluation and staple placement the customer was sent home, the same day, with no additional incident or injury noted.The customer refused to send the device back to the manufacturer for evaluation.No additional information is available.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

It was reported by the customer that while ambulating with the walker the brakes did not engage and the customer fell backwards resulting in the customer sustaining a cut to the head and requiring two staples.

• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11842136
• MDR Text Key: 251361177
• Report Number: 1417592-2021-00095
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2021

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: MDS86850ESKD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 48