MAUDE Adverse Event Report: OSSUR ICELAND ICEROSS SEAL-IN V 34; SILICONE PROSTHETIC LINER

Model Number I-471334

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Tissue Damage (2104)

Event Date 09/15/2016

Event Type  Injury  

Event Description

A below knee amputee patient wearing the iceross seal in v 34 product spent several hours in a pub where he sat for about two hours.As he got up, the socket of the stump slipped.The liner remained at the stump.He and a glass both fell to the ground where he injured his hand on the broken glass and lost a part of his finger.The patient spent a week in the hospital and had his finger tip reattached.The patient lost his finger nail.

Event Description

A below knee amputee patient wearing the iceross seal in v 34 product spent several hours in a pub where he sat for about two hours.As he got up, the socket of the stump slipped.The liner remained at the stump.He and a glass both fell to the ground where he injured his hand on the broken glass and lost a part of his finger.The patient spent a week in the hospital and had his finger tip reattached.The patient lost his finger nail.

• Brand Name: ICEROSS SEAL-IN V 34
• Type of Device: SILICONE PROSTHETIC LINER
• 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: 6033583
• MDR Text Key: 57619329
• Report Number: 3003764610-2016-00007
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-471334
• Device Catalogue Number: I-471334
• Device Lot Number: HF160725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 48 YR
• Patient Weight: 86