MAUDE Adverse Event Report: WINNING INDUSTRIAL CO. LTD. FUTURO (TM) SPORT ADJUSTABLE WRIST SUPPORT; 890.3475 LIMB ORTHOSIS

Catalog Number 09033EN

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

Patient Problem Irritation (1941)

Event Date 06/27/2014

Event Type  Injury  

Event Description

He said he put this brace on last thursday, (b)(6).He wore it all day and then removed it that night.Everything looked fine.On the morning of (b)(6) the skin that had been covered by the brace had what looked like many little mosquito bites.He put a benadryl gel on it but it continued to get worse and developed blisters.By the morning of (b)(6) the blisters had grown to dime size and there was a strong burning sensation.It was a saturday so he went for medical help.He first said he went to the emergency room, then he said, "or the hospital, whatever it's called.This is a real small town." he saw dr (b)(6) and she gave him a shot.He doesn't known what it was.Then she prescribed methylprednisolone tablets.He's been taking those for close to two days now and it's starting to get better, although not totally cleared up yet.

• Brand Name: FUTURO (TM) SPORT ADJUSTABLE WRIST 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 guan, 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: 3926314
• MDR Text Key: 4582459
• Report Number: 2110898-2014-00050
• 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: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 09033EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2014
• 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