MAUDE Adverse Event Report: WINNING INDUSTRIAL CO. LTD. ACE WRIST WRAP; 890.3475 LIMB ORTHOSIS

Catalog Number 203966

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

Patient Problem Irritation (1941)

Event Date 05/19/2014

Event Type  Injury  

Event Description

She had carpel tunnel surgery on (b)(6) 2014 on left had and it was healing good.She woke up from her sleep with her wrist hurting on (b)(6) real bad, so she went to er.They said she sprained it and put it in a splint.She left the er and went to (b)(6).That's when she purchased the ace brace.Put it on in the car and within minutes she felt burning on her wrist and removed the brace right away.Notice rash coming instantly, her skin was getting red, raised with little blisters.Got home and called the doctor (that did the surgery in (b)(6)) and she went into the office the next morning at 9 am.He thought she was having an allergic reaction and had given her a rx for steroid pack and was told to start it right away.It was methyiprednisolo tablet 4 ml.Took the first dose when she picked it up.She then went to her primary doctor appointment a couple hours later that same day.At that appointment her arm, eyes, lips and tongue started to swelled up and she passed out.They called 911 and she was taken to the hospital.She was at the hospital for a few hours and when she left they gave her hydroxyzine 50 mg 1x day for itch and ketoconavole 2% cream apply 2x daily.She was also to continue with the methyiprednisolo tablet 4 mg.

Manufacturer Narrative

Manufacturing name and address should be considered confidential.Product was not returned to the manufacturer.Product was not returned for eval.No conclusion can be drawn.

• Brand Name: ACE WRIST WRAP
• 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.
• Manufacturer Contact: shawn busch ; 910 lila ave; milford, OH 45105 ; 5132725077
• MDR Report Key: 3833461
• MDR Text Key: 4393711
• Report Number: 2110898-2014-00030
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 203966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2014
• 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