MAUDE Adverse Event Report: OSSUR HF ICEROSS SEAL-IN X; LINER

Model Number I-SXT026

Device Problem Fitting Problem (2183)

Patient Problems Pain (1994); Skin Irritation (2076); Impaired Healing (2378)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

No indication of material or manufacturing failure could be identified based on information provided.This type of issue has not been recorded before as a result of this or predicate devices.No product was returned and analysis was performed based on information provided via medwatch.It is concluded that the subject is likely to have an underlying condition leading to the severity of ulceration.Diabetic patients and peripheral vascular disease patients are known to be ulcer prone which may also have contributed to said issue.As information is scarce in the claim and relation cannot be made to product malfunction, further action is not considered warranted.

Event Description

Patient was fitted with a 1 1/2 in silicone band that felt like a "tourniquet", caused pain and developed a non-healing blood blister.

• Brand Name: ICEROSS SEAL-IN X
• Type of Device: LINER
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8132735
• MDR Text Key: 129313621
• Report Number: 3003764610-2018-00007
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• PMA/PMN Number: EXCEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-SXT026
• Device Catalogue Number: I-SXT026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention