MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SUPER LIGHT ROLLATOR

Catalog Number WRX449724

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

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Skull Fracture (2077)

Event Date 05/13/2015

Event Type  Injury  

Event Description

The end user was sitting on the rollator and being pushed.She fell and suffered right rib and skull fractures.She was admitted to the hospital.

Manufacturer Narrative

It was reported that while sitting on the rollator, the end user was being pushed across a street and up a metal ramp.The rollator collapsed and the end user fell, hitting her head on the ramp.She sustained right rib fractures, a right occipital skull fracture and a head laceration that was repaired with minor suturing.She was admitted into the hospital, the device is not intended to be used as a transport device while someone is sitting on it.The reporter, who is the end user's son, confirmed that he did receive a manual with the rollator.In the manual it states "do not attempt to move the rollator while you or anyone is sitting on the seat." a sample has not been received for evaluation and no photos were sent.The overall care and condition of the rollator is not known.We have no information to indicate a manufacturing defect caused or contributed to the incident.A root cause has not been determined.Based on the information provided, we cannot rule out user error.

• Brand Name: SUPER LIGHT ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4860122
• MDR Text Key: 22251296
• Report Number: 1417592-2015-00049
• 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: 06/11/2015

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: WRX449724
• Device Lot Number: M140772163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 64