MAUDE Adverse Event Report: REBORN MEDICAL CO., LTD. DRIVE MEDICAL; MECHANICAL WALKER

Model Number 10210

Device Problem Collapse (1099)

Patient Problems Fall (1848); Skull Fracture (2077)

Event Date 01/26/2014

Event Type  Injury  

Event Description

Drive medical has received a patient complaint about an incident involving a walker imported and distributed by drive medical.The claimant claims that he was walking with the walker and item collapsed causing him to fail.Claimant was lying on his left side when his daughter found him and he injured his head.Claimant had surgery due to blood clot in his head.This mdr report is based on the information provided by the claimant's daughter.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): REBORN MEDICAL CO., LTD.; guangdong province ; CH
• MDR Report Key: 3679292
• MDR Text Key: 20638635
• Report Number: 2438477-2014-00002
• 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
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/27/2014,01/31/2014

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: 10210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2014
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 95