ICEROSS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for ICEROSS manufactured by Ossur.

Event Text Entries

[96148429] Reporter called to report that he had an appointment with hanger clinic for a new prosthetic liner. He was approved by his health insurance and met is deductible to receive the medical device that he needed to fit his prosthetic leg. Without his knowledge the hanger clinic representative fitted him with a 1 1/2 in silicone band that felt like a "tourniquet", caused pain and developed a non-healing blood blister. The reporter stated that the representative from the hanger clinic told him to use caltrans to treat his wound. The reporter visited the hanger clinic again for liner assessment and that is when he was told that by the hanger company rep. That he was testing the 1 1/2 liner and that he would remove the old one and place the one that matched his prosthetic better; which was 6-7 inches wide. The reporter stated that his wound continued to get worse and that on (b)(6) 2017 he had the wound debrided and while in surgery he lost an additional six inches of leg tissue. He is under medical treatment for infection in the tissues and bone. Due to his recent surgery he will not be able to work in the coal mine for at least 3 months, not be able to use his prosthetic, and this will impact his activities of daily living.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074296
• MDR Report Key: 7154509
• Date Received: 2017-12-28
• Date of Report: 2017-12-28
• Date of Event: 2017-06-30
• Date Added to Maude: 2017-12-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: ICEROSS
• Generic Name: COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
• Product Code: ISH
• Date Received: 2017-12-28
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OSSUR

Device Sequence Number: 2

• Brand Name: ICEROSS
• Generic Name: COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
• Product Code: ISH
• Date Received: 2017-12-28
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: OSSUR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2017-12-28