MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; UNKNOWN ROLLATOR DEVICE

Catalog Number UNKNOWN

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

Patient Problems Head Injury (1879); Hemorrhage, Subdural (1894)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

Prior to the manufacturer's aware date indicated in this report, this incident had not been previously reported to medline industries, inc.It was reported that on (b)(6) 2017, during a building evacuation for an alleged fire alarm in a courthouse, the end-user, who reportedly has an unidentified disability and was using a portable oxygen tank at the time of the incident, sat on his rollator's seat while his wife was attempting to assist in transporting him out of the building.Per report, when they reached the building doorway, the rollator's wheels abruptly stopped and got caught on the lip of the doorway threshold resulting in the end-user falling and hitting his head onto the ground.Reportedly, due to the crowded conditions at the building doorway, visibility of the doorway threshold was blocked.Per report, the end-user required unidentified medical treatment and hospitalization due to a traumatic head injury (subdural hematoma).The sample was not returned for evaluation.Of note, the owner's manual for this device, medline's rollator safety guidelines' specifically states that to ensure safety in using the medline rollator, the following relevant safety information and instructions must be followed: rollators are for individual use only and are not to be used as wheelchair.Do not attempt to move the rollator while you or anyone is sitting on the seat.Do not use the seat to transport people or objects.Do not use the seat to carry or move anything.Serious injury to you and/or damage to the rollator frame or wheels may result from improper use.The information we have received regarding this incident indicates the end user did not use the device as intended.We have no information to suggest a manufacturing defect existed.User error most likely caused or contributed to this incident.Due to the reported injury and subsequent hospitalization, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during use of an unknown medline rollator, the end-user fell resulting in a head injury (subdural hematoma).

• Type of Device: UNKNOWN ROLLATOR DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7535031
• MDR Text Key: 108951600
• Report Number: 1417592-2018-00041
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/22/2018

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR