MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP SIMPLICITY 3 BLUE COVER LOCKING LINER

Model Number 6Y521=290-5

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

Patient fell, was injured by fall and taken by ambulance to hospital.

• Brand Name: SIMPLICITY 3 BLUE COVER LOCKING LINER
• Type of Device: LINER
• Manufacturer (Section D): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; salt lake city UT 84120
• Manufacturer (Section G): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; salt lake city UT 84120
• Manufacturer Contact: caleb beck ; 3820 west great lakes drive; salt lake city, UT 84120 ; 8019746647
• MDR Report Key: 4786335
• MDR Text Key: 5852525
• Report Number: 1721652-2015-00001
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 6Y521=290-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization