MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR,X-WIDE,HEAVY DUTY,400 LBS.

Catalog Number MDS86800XW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 09/07/2023

Event Type  Injury  

Event Description

According to the customer, he used the rollator with a "broken wheel" to go on an escalator when the "broken wheel got caught in the folding steps" causing him to fall and land on the escalator steps.

Manufacturer Narrative

According to the customer, he used the rollator with a "broken wheel" to go on an escalator when the "broken wheel got caught in the folding steps" causing him to fall and land on the escalator steps.The customer reported he was helped to his feet, and an ambulance was called to take him to the hospital.The customer reported he was admitted to the hospital for "two days", they ran "test" and "x-rays", and determined he had a "badly torn rotator cuff".The customer reported he was referred to a surgeon but, has not made an appointment at this point.The customer reported his left shoulder hurts and can't be lifted over his head.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.

Manufacturer Narrative

Update h6: investigation conclusions.

• Type of Device: ROLLATOR,X-WIDE,HEAVY DUTY,400 LBS.
• 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: 17881129
• MDR Text Key: 325036618
• Report Number: 1417592-2023-00402
• 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,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86800XW
• Device Lot Number: 88522030002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• 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