MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD CAREX; ROLLATOR

Model Number FGA221EQ WMRT

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bruise/Contusion (1754); Limb Fracture (4518)

Event Date 09/16/2020

Event Type  Injury  

Event Description

Customer claims the walker broke causing her to fall.They purchased about 8 months ago.She was coming out of the drug store and went to put the rollator down off of the curb.It collapsed as she did it causing her to fall.She went to the emergency room where they diagnosed her as having a fractured left wrist and a fractured left leg.The next day they went to their regular doctor who sent her to an orthopedic doctor.The orthopedic doctor didn't see any fractures, but said that she had internal bruising and bleeding on her left side.She then had more x-rays which showed that she had a broken bone in her left lower leg.She said that the rollator collapsed as she went to step down off of the curb, nothing broke.Page 1 of the warning/instructions for use state on the front page, top right bullet under "instructions for use and warnings" states the following: always make sure the rollator is fully opened and the folding bar is locked in the down position before use.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD; no. 58 yu long 3 road; dong sheng town; zhong shan city guangdong, ; CH
• MDR Report Key: 10740406
• MDR Text Key: 213204058
• Report Number: 3012316249-2020-00033
• 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: 10/27/2020

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 Model Number: FGA221EQ WMRT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2020
• Distributor Facility Aware Date: 10/07/2020
• Event Location: Other
• Date Report to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 57