MAUDE Adverse Event Report: WINNING INDUSTRIAL CO LTD FUTURO HINGED KNEE BRACE; 890.3475 LIMB ORTHOSIS

Catalog Number 48579EN

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

Patient Problem Irritation (1941)

Event Date 06/09/2014

Event Type  Injury  

Event Description

He wore the product (b)(6) 2014 through (b)(6) 2014.She stated he "broke out" and was mainly where the brace was on his skin.He had many red little bumps on his skin where the brace touched his skin that itched.He had to go to urgent care.They prescribed medication to him.They gave him prednisone and atarax.The area where the red bumps were on his skin is beginning to clear up now and is looking better.

Manufacturer Narrative

Manufacturing name and address should be considered confidential.

• Brand Name: FUTURO HINGED KNEE BRACE
• Type of Device: 890.3475 LIMB ORTHOSIS
• Manufacturer (Section D): WINNING INDUSTRIAL CO LTD; sha jing keng industrial zone, fu shan dist.,; liao bu, don guan,; gunagdong ; CH
• Manufacturer (Section G): WINNING INDUSTRIALS CO. LTD.; sha jing keng industrial zone, fu shan dist liao bu,; don guan; guangdong ; CH
• Manufacturer Contact: shawn busch ; 910 lila ave; milford, OH 45150 ; 5132725077
• MDR Report Key: 3874920
• MDR Text Key: 4512479
• Report Number: 2110898-2014-00041
• 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: Other
• Type of Report: Initial
• Report Date: 06/09/2014

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: 48579EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 06/11/2014
• 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