MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; TRANSLATOR, ROLLLATOR/TRANSPORT CHAIR

Catalog Number MDS808200TRR

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the end user got out of a car and was ambulating on pavement.She attempted to turn right and apparently the device did not respond.She lost her footing and fell to her left side, suffering a fractured hip.She was admitted to the hospital.It is not known what treatment, if any, was initiated.The incident and subsequent fall was not witnessed.No lot number was provided.We have no sample or photos to evaluate.We have minimal information regarding what actually transpired.It is not known what role the device played in the reported incident.A root cause has not been determined.However, in an abundance of caution, due to the reported incident and subsequent injury, this medwatch is being filed.Device not returned.

Event Description

The end user fell while ambulating with the device and fractured her hip.

• Type of Device: TRANSLATOR, ROLLLATOR/TRANSPORT CHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5818799
• MDR Text Key: 50314744
• Report Number: 1417592-2016-00075
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS808200TRR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR
• Patient Weight: 59