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

Catalog Number MDS86850ESKD

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, she was walking with the rollator when "a screw broke and the device collapsed" causing her to fall, hit her head, and "pull her shoulder".The customer reported went to her physician after the reported event and received a "cortisone shot" in her shoulder.The customer reported she has required no medical intervention or attention for her head.The customer reported she is continuing to experience pain in her shoulder.Sample was requested for return evaluation.No additional information is available at this time.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, she was walking with the rollator when "a screw broke and the device collapsed" causing her to fall, hit her head, and "pull her shoulder".

• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• 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: 16555080
• MDR Text Key: 311476011
• Report Number: 1417592-2023-00108
• 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: 03/16/2023

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: MDS86850ESKD
• Device Lot Number: 8852110002
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/16/2023
• 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