MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE MEDICAL; MECHANICAL WALKER

Model Number R728BL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Laceration(s) (1946)

Event Date 05/13/2017

Event Type  Injury  

Event Description

(b)(4) received notification of an incident involving a rollator that drive imports and distributes.The enduser came into contact with the brake housing of the rollator which allegedly caused her to suffer a gash to her ankle.The enduser went to the er to dress the wound and it allegedly became infected in a week.She is now in physical therapy.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; no.1 chuangye street; southwest industrial district; matou, handan city, hebei 05604 6; CH 056046
• MDR Report Key: 6763185
• MDR Text Key: 81697902
• Report Number: 2438477-2017-00063
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/03/2017,07/06/2017

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: 08/03/2017
• Distributor Facility Aware Date: 07/06/2017
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 08/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 95