MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE MEDICAL; MECHANICAL WALKER

Model Number R728BL

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

(b)(4) received notification of an incident involving a rollator that (b)(4) imports and distributes.The enduser was using the rollator when allegedly, the handlebar broke off causing him to fall and injure his right hand.(b)(4) is in the process of recovering the rollator for evaluation.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao zhejiang, 31540 8; CH 315408
• MDR Report Key: 6834401
• MDR Text Key: 84130853
• Report Number: 2438477-2017-00072
• 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: 08/31/2017,07/26/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: R728BL
• 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: 08/31/2017
• Distributor Facility Aware Date: 07/26/2017
• Date Report to Manufacturer: 08/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• 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: 58