MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, BASIC, BLACK, STEEL, 6"

Catalog Number MDS86830EBLS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/17/2023

Event Type  Injury  

Event Description

According to the customer the rollator rolls away from him when he reaches down for it because, it is "too short" for his height and has caused him to fall "3 times".

Manufacturer Narrative

According to the customer the rollator rolls away from him when he reaches down for it because, it is "too short" for his height and has caused him to fall "3 times".The customer reported he started having pain in his shoulder after the reported incident that required him to see a physician that prescribed him "lidocaine patches, tramadol, tylenol, and flexeril".The sample has been requested to be returned for 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.

• Type of Device: ROLLATOR, BASIC, BLACK, STEEL, 6"
• 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: 16931300
• MDR Text Key: 315211920
• Report Number: 1417592-2023-00216
• 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: 05/15/2023

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: MDS86830EBLS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/15/2023
• 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