MAUDE Adverse Event Report: WINNING INDUSTRIAL CO. LTD., FUTURO SPORT ADJ KNEE SUPPORT; 890.3475 LIMB ORTHOSIS

Catalog Number 09039ENT

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

Patient Problem Irritation (1941)

Event Date 04/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, customer wore the sport adjustable knee brace.Had the brace on for about 2 hours when she noticed her leg was itching, red, swollen, and on the back of her knee were blister and bumps.Went to urgent care that night and was given an ointment called clobetasol propionate to use on her leg along with a steroid injection.

Manufacturer Narrative

Method: product was not returned to the manufacturer.Results: product was not returned for evaluation.Conclusions: no conclusion can be drawn.

• Brand Name: FUTURO SPORT ADJ KNEE SUPPORT
• 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 duan, guangdong ; 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: 3854908
• MDR Text Key: 18792804
• Report Number: 2110898-2014-00033
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2014

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: 09039ENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/28/2014
• 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
• Patient Outcome(s): Other