MAUDE Adverse Event Report: INVACARE INVACARE 9000 TOPAZ

Model Number 9TPZ

Device Problem Protective Measures Problem (3015)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Post Traumatic Wound Infection (2447)

Event Date 11/30/2015

Event Type  Injury  

Event Description

Patient sustained a left fifth fingertip amputation.Injury occurred when patient sat in wheelchair and his finger was pinched in the seat-locking mechanism.Patient transferred to emergency department where he was stabilized and treated by an orthopedic surgeon.Wound was irrigated, cleansed, closed, and dressed.Patient discharged home from emergency department.Subsequent admission from (b)(6) 2015 for left hand infection which improved with antibiotic therapies.

• Brand Name: INVACARE 9000 TOPAZ
• Manufacturer (Section D): INVACARE; elyria OH
• MDR Report Key: 5305552
• MDR Text Key: 33832582
• Report Number: 5305552
• Device Sequence Number: 1
• Product Code: IOR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2015,11/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9TPZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Weight: 77