MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ROLLATOR

Catalog Number MDS86845B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the end user fell as she was getting out of her vehicle when a weld on the right side of the device failed.She had x-rays taken and there were no fractures.She was treated with steroids and physical therapy for an injured left shoulder.Multiple attempts were made to get the sample for evaluation.The sample has not been returned.The overall condition, care and maintenance of the rollator is unknown.Photos of the sample have been received but a root cause cannot be determined.Due to the reported injury and in an abundance of caution, this medwatch is being filed.

Event Description

The end user fell while using the rollator.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5574715
• MDR Text Key: 42606189
• Report Number: 1417592-2016-00038
• 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: Patient
• Type of Report: Initial
• Report Date: 04/13/2016

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: MDS86845B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/13/2016
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 109