MAUDE Adverse Event Report: A & I VIETNAM MEDICAL EQUIPMENT CO., LTD DRIVE MEDICAL; WHEELCHAIR

Model Number STD28DFA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Crushing Injury (1797)

Event Date 02/23/2016

Event Type  Injury  

Event Description

(b)(4) received notice regarding the incident from the provider involving a wheelchair, a product imported and distributed by (b)(4).The end user was pushing the seat down to get it to latch.Her finger was allegedly pinched in the mechanism when the seat closed on her, and the finger was amputated as a result.This report is based on the information provided from the provider.

• Brand Name: DRIVE MEDICAL
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): A & I VIETNAM MEDICAL EQUIPMENT CO., LTD; my xuan a2 industrial zone; tan thanh dist ba ria-vung tau, ; VM
• MDR Report Key: 5530416
• MDR Text Key: 41304523
• Report Number: 2438477-2016-00015
• Device Sequence Number: 1
• Product Code: IOR
• 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: 03/27/2016,02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: STD28DFA
• 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: 03/27/2016
• Distributor Facility Aware Date: 02/26/2016
• Event Location: Other
• Date Report to Manufacturer: 03/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR