MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR

Catalog Number MDS86826W

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 12/18/2013

Event Type  Injury  

Event Description

The end user fell while using the rollator and suffered a dislocated shoulder.

Manufacturer Narrative

The end user reported that the rollator slid away from her and she fell on top of it.She suffered a dislocated shoulder.It was repositioned under twilight anesthesia and she was sent home with an immobilizer.The sample was not returned for evaluation and no lot number was reported.She stated that she had not performed any maintenance on the device during the year she had owned it.A root cause was not determined but it is possible the brakes were not adjusted properly.The manual states the brakes should be checked and adjusted as necessary prior to use.Without the sample, lot number or photos, we have not confirmed it was a medline device.However, due to the reported injury, and in an abundance of caution, this medwatch is being filed.

• Brand Name: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3608908
• MDR Text Key: 4088927
• Report Number: 1417592-2014-00007
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/17/2014

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: MDS86826W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 110