MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP ROLLATOR, SUPERLIGHT, BURGUNDY

Catalog Number MDS86825SLR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 11/18/2021

Event Type  Injury  

Event Description

The customer reported that he was walking with the device and the front wheel fell off resulting in the customer falling to the ground, cutting his arm and needing stitches for the cut.

Manufacturer Narrative

The customer reported that he was walking with the device and the front wheel fell off resulting in the customer falling to the ground.The customer stated that he was able to get back up but went to the hospital due to a cut on his arm that required him to get 4 stitches.The customer did not sustain any other injuries and was released from the hospital the same day.The customer went back to his doctor to have stitches removed with no additional follow up medical attention required.The device was returned for evaluation and it was discovered that the left rear wheel does not roll correctly and it makes a clicking sound as it rolls.The rear left leg frame tubing seems to be slightly bent inward.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: ROLLATOR, SUPERLIGHT, BURGUNDY
• Type of Device: ROLLATOR, SUPERLIGHT, BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14047754
• MDR Text Key: 288853680
• Report Number: 1417592-2022-00049
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86825SLR
• Device Lot Number: 05420030009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG