MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, X-WIDE,HEAVY DUTY, 400 LBS.

Catalog Number MDS86800XW

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 09/08/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user was sitting on the rollator when he leaned backward and the device "collapsed" underneath him.The end-user was unable to identify which part of the device "collapsed" or if there was break to the frame or a wheel.According to the end-user, the rollator's brakes were engaged at the time of this incident.The end-user experienced a backward fall.He hit the back of his head on a wall and then stated that he hit his head on his chest.The end-user experienced pain to his chest and unidentified "cracked" teeth.He denies seeing a medical provider and denies receiving medical intervention or follow-up care.Reportedly, since the incident, the end-user has been using his neighbor's unidentified "muscle relaxer cream" and applying the cream to his chest.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, 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 the end-user experienced a backward fall while sitting on the rollator and cracked his teeth.

• Type of Device: ROLLATOR, X-WIDE,HEAVY DUTY, 400 LBS.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7922085
• MDR Text Key: 122173874
• Report Number: 1417592-2018-00103
• 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: Other
• Type of Report: Initial
• Report Date: 10/01/2018

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: MDS86800XW
• Device Lot Number: 88516090048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Weight: 164