MAUDE Adverse Event Report: WINNING INDUSTRIAL CO. LTD FUTURO (TM) MOISTURE CONTROL KNEE; 890.3475 LIMB ORTHOSIS

Catalog Number 45696EN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Irritation (1941)

Event Date 05/23/2014

Event Type  Injury  

Event Description

Purchasing futuro moisture control knee support size medium (b)(4) approximately two weeks ago.Wore the product for 24 hours, overnight approximately 1 1/2 weeks ago.He noticed many red dots and was itching after he removed the knee support.Customer stated, "then the rash spread all over." he went to the emergency room at (b)(6) the first time on (b)(6) 2014.He was prescribed prednisone, which did not work.He went in again on (b)(6) 2014 because the "rath" was worse and spread to his other leg.The doctor gave him a lotion.Customer stated he does not remember which lotion or the name because it did not work.Went in this morning (b)(6) 2014 and doctor prescribed the following: (customer spelled the names) dicloxacillin 250 milligram capsules.Instructions: take 2 capsules by mouth twice per day and up to 10 days.Clobetasol propionate.Prescribed two tubes.Instructions: twice daily, once in the morning and once at night.Then had to get a shot this morning due to his arm all the way down to his wrist was red and they told him it was an infection (he did not specify if this was related to use the knee support).The shot was to get rid of the infection, but customer does not recall what it was called.The main point is that he really liked the product and how comfortable it was before noticing the "rash".He did find out he is allergic to neoprene.Years ago he wore a nicotine patch that had neoprene in it and developed a rash, as well.Allergic reaction per doctor.

Manufacturer Narrative

Manufacturing name and address should be considered confidential.

• Brand Name: FUTURO (TM) MOISTURE CONTROL KNEE
• Type of Device: 890.3475 LIMB ORTHOSIS
• Manufacturer (Section D): WINNING INDUSTRIAL CO. LTD; sha jig keng industiral zone; fu shan district, liao bu, don guan; guangdong ; CH
• Manufacturer Contact: shawn busch ; sha jing keng industrial zone, fu shan; dist liao bu, don guan; guangdong ; 5132725077
• MDR Report Key: 3853515
• MDR Text Key: 4621063
• Report Number: 2110898-2014-00035
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 45696EN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 05/30/2014
• 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: Initial
• Patient Sequence Number: 1