MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; ROLLATOR

Model Number 10215BL-1

Device Problem Fracture (1260)

Patient Problems Fall (1848); Muscle/Tendon Damage (4532)

Event Date 10/08/2021

Event Type  Injury  

Event Description

(b)(6) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will submit a follow-up when additional data becomes available.While in use the fork broke from the frame and the user fell.She went to the er after falling.They wrapped her leg in an ace bandage and recommended she see a specialist.She was given tylenol for the pain.She sustained an injury to er knee which was diagnosed as a possible torn tendon or meniscus.The specialist had her take an mri.She was prescribed three medications including pain meds and metropod.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; 589 hualu road,; huashi town; jiangyin city, jiangsu, 21442 1; CH 214421
• MDR Report Key: 12696783
• MDR Text Key: 278346456
• Report Number: 2438477-2021-00059
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/26/2021

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: 10215BL-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Distributor Facility Aware Date: 10/15/2021
• Device Age: 2 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 102