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

Catalog Number MDS86800XWS

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact on (b)(6) 2022 while using the rollator 'the bolt on the front wheel of the walker broke causing the client to fall to the ground whereby she sustained a laceration to her leg' requiring medical treatment and intervention.No additional information is available at this time.The device is available but has not been returned for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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 contact on (b)(6) 2022 while using the rollator 'the bolt on the front wheel of the walker broke causing the client to fall to the ground whereby she sustained a laceration to her leg' requiring medical treatment and intervention.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• 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: 16035317
• MDR Text Key: 306009351
• Report Number: 1417592-2022-00242
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• 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: 12/22/2022

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: MDS86800XWS
• Device Lot Number: 88521110001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/22/2022
• 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): Required Intervention
• Patient Sex: Female