MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR

Catalog Number MDS86850EP

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2014

Event Type  Injury  

Event Description

The end user fell while using the rollator and fractured her shoulder.

Manufacturer Narrative

It was reported that a wheel came off the rollator and the end user fell, fracturing her shoulder.The fracture was surgically repaired.Minimal details were provided regarding the incident.How the device was being used at the time of the incident is not known.There were no previous issues reported for this rollator during the 6 months it was used by the end user.A sample has not been returned for evaluation.A root cause has not been determined.

• 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: 4503692
• MDR Text Key: 19507825
• Report Number: 1417592-2015-00009
• 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: 02/02/2015

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: MDS86850EP
• Device Lot Number: C131283135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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; Required Intervention
• Patient Age: 72 YR