MAUDE Adverse Event Report: COM-DA HEALTHCARE CO., LTD; ROLLATOR

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 06/01/2022

Event Type  Injury  

Event Description

End user called to report her rollator.She got it from midsouth medical about 6 months ago, and since then the brakes have continued to "fail", causing her to fall 3 times.She mentioned on the phone that the spring within the brake assembly fell off, the brake handles are hanging down and no longer secure, the brake assembly has come apart from the frame at the bottom near the caster.She said midsouth medical has adjusted the brakes once, and since then the issue has not gotten better and the brakes continue to not fully stop the rollator when the hand brakes are pulled.Patient weight: 365 pounds, is now down to 240 pounds.End user said she prefers a larger (bariatric) rollator since she had a bariatric unit before and is used to it.End user claims rollator was taken in to dealer only a few weeks after she purchased it and the brakes were adjusted by the dealer before any of the times she fell.First fall instance was in the patients home in june, end user fell and received elbow injuries.Called ambulance to help her get up, the ems workers bandaged her elbow.Received large cut on her leg, said she got 10 stitches.Advised the end user to stop using this unit immediately.End user confirmed the left handle was loose after returned from midsouth medical for an adjustment, and continued to get loose over time and with use.End user was able to provide the uniform registration #, (b)(4).

• Type of Device: ROLLATOR
• Manufacturer (Section D): COM-DA HEALTHCARE CO., LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city guangdong, cn ; CH
• MDR Report Key: 16536833
• MDR Text Key: 311227773
• Report Number: 3012316249-2023-00003
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2023
• Distributor Facility Aware Date: 02/21/2023
• Event Location: Home
• Date Report to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 109 KG