MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR

Catalog Number MDS86810

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

Patient Problem Wound Dehiscence (1154)

Event Date 11/01/2014

Event Type  Injury  

Event Description

The end use fell while using the rollator and suffered a partial dehiscence of a surgical incision on her right foot.

Manufacturer Narrative

The end user reported that she fell when the rollator moved as she sat onto the seat.She suffered partial dehiscence of a surgical incision she had on her right foot.The physician left the are of the incision open and covered it with a bandage.The sample was not returned for evaluation.The end user reported that prior to the incident, when she first purchased the device from a local dme company, the brakes did not appear to be working correctly but she continued to use it.The sample was not returned for evaluation.Based on the possibility that the brakes were not adjusted properly.The owner's manual states that the brakes should be checked and adjusted as necessary prior to use.We have not determined that a manufacturing defect was present.

• Brand Name: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4418368
• MDR Text Key: 15114944
• Report Number: 1417592-2015-00002
• 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: 01/06/2015

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: MDS86810
• Device Lot Number: M140355484
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 55 YR
• Patient Weight: 86