MAUDE Adverse Event Report: OSSUR ICELAND ICEROSS SEAL IN V 20; COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Model Number I-471320

Device Problems Component Missing (2306); Torn Material (3024)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Amputee patient wearing iceross seal-in v 20 claims the seal tore and the patient lost the vacuum and came out of the socket causing a leg wound which required a wound vac for 3 months.The patient claims they developed patella tendonitis as a result.

Event Description

Amputee patient wearing iceross seal-in v 20 claims the seal tor and the patient lost the vacuum and came out of the socket causing a leg wound which required a wound vac for 3 months.The patient claims they developed patella tendonitis as a result.

• Brand Name: ICEROSS SEAL IN V 20
• 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 ; 9493823741
• MDR Report Key: 5505710
• MDR Text Key: 40533283
• Report Number: 3003764610-2016-00003
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-471320
• Device Catalogue Number: I-471320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention