MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DIV30 DME - MISCELLANEOUS

Catalog Number DIV30

Device Problem Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/04/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023, her mother was walking with her rollator when "a screw came out and the rollator collapsed" causing her to fall onto the floor.The customer reported her mother stayed overnight in the hospital where they confirmed a rib fracture with an x-ray and found a "small amount of blood in the lungs".The customer reported that her mother was prescribed "lidocaine patches" for pain but, no other medical intervention was performed.The customer reported her mother is continuing to use the broken device.This writer advised the customer to not use the broken device.Sample is not available to be returned.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, on (b)(6) 2023, her mother was walking with her rollator when "a screw came out and the rollator collapsed" causing her to fall onto the floor.

• Type of Device: DIV30 DME - MISCELLANEOUS
• 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: 16582955
• MDR Text Key: 311677454
• Report Number: 1417592-2023-00119
• 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: 03/21/2023

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: DIV30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/21/2023
• 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