MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C98-3=99

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Concussion (2192)

Event Type  Injury  

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.

Event Description

Patient was walking down stairs while carrying a computer at work.Patient bumped his head and suffered a concussion.He was taken to the er to be treated.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7552315
• MDR Text Key: 109489204
• Report Number: 9615892-2018-00014
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3=99
• Device Catalogue Number: 3C98-3=99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 113