MAUDE Adverse Event Report: VALENTINE INTL. LTD. CAREX; ROLLING WALKER

Model Number FGA22200 0000

Device Problem Unintended Collision (1429)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The user hit a crack on the sidewalk while using the rollator, and the rollator's left front wheel bent sideways.The user fell forward and hit his head and shoulder.He did not seek medical attention.The user had this rollator for about a week and a half.The event is reported as having occurred on a cement surface while the user was pushing the rollator.The device involved with this event was returned to compass health brands and evaluated on 8/31/2017 - the customer's complaint could not be duplicated from a review of the returned device.The frame and wheels of the returned rollator were not found to be bent anywhere on the unit.The right front frame did have a stress mark in its metal where the paint was chipping.The frame did not crack, nor was a weld broken.Again, the customer's complaint could not be duplicated from a review of the returned device.

• Brand Name: CAREX
• Type of Device: ROLLING WALKER
• Manufacturer (Section D): VALENTINE INTL. LTD.; 8th fl., no. 149, sec. 2,; ta tung rd.; hsichih city, taipei hsien tai, 221 ; TW 221
• MDR Report Key: 6871140
• MDR Text Key: 86439882
• Report Number: 3012316249-2017-00118
• 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: 09/15/2017

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: FGA22200 0000
• Device Catalogue Number: A222-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Distributor Facility Aware Date: 08/21/2017
• Event Location: Other
• Date Report to Manufacturer: 09/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 132