MAUDE Adverse Event Report: FOSHAN JOIN MEDICAL CO. LTD. ENDURANCE HD; ROLLATOR

Model Number JI-9044

Device Problems Unintended Collision (1429); Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Date 04/16/2020

Event Type  malfunction  

Event Description

Patient was walking on a gravel surface when the right rear wheel allegedly bent inward causing a fall.No injury or medical attention was sought.

• Brand Name: ENDURANCE HD
• Type of Device: ROLLATOR
• Manufacturer (Section D): FOSHAN JOIN MEDICAL CO. LTD.; 29th building, no. 1 liandu st; shunde district; foshan, guangdong 52830 3; CH 528303
• MDR Report Key: 10057131
• MDR Text Key: 197944825
• Report Number: 1056127-2020-00003
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131432
• UDI-Public: 754756131432
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JI-9044
• Device Catalogue Number: W1802B-14
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2020
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 204