MAUDE Adverse Event Report: OSSUR ICELAND ICEROSS COMFORT 36; COMPONENT, EXTERNAL LIMB, ANKLE/FOOT

Model Number I-540636

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/13/2015

Event Type  Injury  

Manufacturer Narrative

Limited information provided to us through attorney.No details related to claim of 'significant injuries to his right leg and other portions of his body'.

Event Description

Amputee patient walking down the hall at home and fell.There is a claim of significant injuries to his right let and other portions of his body.The user took the prosthetic to the local cpo who resolved the issue.Therapist claims the pin worked its way out of the sleeve.

• Brand Name: ICEROSS COMFORT 36
• Type of Device: COMPONENT, EXTERNAL LIMB, ANKLE/FOOT
• Manufacturer (Section D): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6118986
• MDR Text Key: 60622544
• Report Number: 3003764610-2016-00009
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-540636
• Device Catalogue Number: I-540635
• Device Lot Number: 441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention