MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO., LTD CAREX; ROLLATOR

Model Number FGA22100 0000

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Fall (1848); Muscle Spasm(s) (1966); Pain (1994); Ambulation Difficulties (2544)

Event Date 09/15/2017

Event Type  Injury  

Event Description

The user was walking down the street, when the front wheels of the rollator flipped her.The user fell on top of the rollator.The user does not know if she had hit a crack or a branch or not.The event scared her so badly, that she urinated on herself.She could not walk because she was having muscle spasms in her neck, back, and her knees, as well as her right shoulder because of the fall.She went to the er a day later, and they treated her for the spasms/pain.The user's sister is looking for compensation for the user's pain and suffering, as the user is reported as still being in bed, unable to walk correctly.The event is reported as having occurred outside on cement.The hardware of the rollator is reported as having seemed tight, and the push buttons are reported as having protruded fine.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO., LTD; unit 1, no 66 yu long 3 road; dong sheng town; zhong shan city, 52841 4; CH 528414
• MDR Report Key: 6954472
• MDR Text Key: 89484604
• Report Number: 3012316249-2017-00125
• 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: Patient
• Type of Report: Initial
• Report Date: 10/17/2017

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 Model Number: FGA22100 0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Distributor Facility Aware Date: 09/18/2017
• Event Location: Other
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 116