MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, BARIATRIC, BASIC STEEL

Catalog Number MDS86800XWS

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, they applied the brakes prior to stepping up on a curb but, the "handle bars" were loose due to continued issues of "screws falling out".The customer reported they fell on the concrete hitting both knees and "twisting" their back.The customer reported their knees were bruised and bleeding.The customer reported they applied "ointment" to their knees and went to see a physician for their back.The customer reported the physician performed "x-rays" that did not result with any "broken bones" and prescribed "tramadol" for pain.This writer advised the customer to not use the broken rollator.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, 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, they applied the brakes prior to stepping up on a curb but, the "handle bars" were loose due to continued issues of "screws falling out".The customer reported they fell on the concrete hitting both knees and "twisting" their back.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17818157
• MDR Text Key: 324266670
• Report Number: 1417592-2023-00390
• 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: 09/26/2023

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: MDS86800XWS
• Device Lot Number: 88521110001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/26/2023
• 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