MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR

Catalog Number MDS86825

Device Problem Insufficient Information (3190)

Patient Problem Contusion (1787)

Event Date 06/04/2014

Event Type  Injury  

Manufacturer Narrative

While sitting on the rollator, the family member pulled the end user a short distance outside.The end user then fell when the rollator apparently folded underneath him.He hit his head and was admitted to the hosp for observation.No serious injury was diagnosed.The sample was returned and evaluated.The screws that attach the brake handles were removed which allowed the handles to spin.The brakes were found to be properly adjusted.No functional issues or mfg defects were identified during the sample evaluation.When the rollator was opened with the folding mechanisms seated flat, the device did not fold underneath with someone seated on it.It is not known if the device was secured in the open position prior to use.The owner's manual also states that the device is not intended to be moved when an end user is seated on it.At this time, we have no info to suggest a mfg defect caused or contributed to the incident.User error most likely caused the incident.

Event Description

The end user fell while sitting on the rollator.

• 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: 3964172
• MDR Text Key: 21165266
• Report Number: 1417592-2014-00067
• 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: 07/10/2014

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: MDS86825
• Device Lot Number: A110890760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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: 74 YR
• Patient Weight: 84