MAUDE Adverse Event Report: WINNING INDUSTRIAL CO, LTD ACE KNEE BRACE WITH DUAL SIDE STABILIZER; LIMB ORTHOSIS

Catalog Number 200290

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

Patient Problem Irritation (1941)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Customer called to report that she had an allergic reaction to our product (200290).On (b)(6) 2014 at approx 11:00 am customer put the product on right knee and had the brace on for approx 2 hours removing approx 1:00 pm.One the brace was removed she noticed that her knee was red, an hour later there was swelling, hives, and itching around where the brace was on the knee.Customer took benadryl friday night, all day saturday.On sunday morning at approx () she went to emergency room.Customer was given (3) rx's prednisone 50mg (1 tab by mouth), famotidine 20mg (1 tab 2x day) and benadryl 50 mg every 4-6 hours as needed for itching.

Manufacturer Narrative

Mfg name and address should be considered confidential.Method - product was not returned to the mfr.Result - product was not returned for eval.Conclusion - no conclusion can be drawn.

• Brand Name: ACE KNEE BRACE WITH DUAL SIDE STABILIZER
• Type of Device: 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 45150 ; 5132725077
• MDR Report Key: 3836102
• MDR Text Key: 19086647
• Report Number: 2110898-2014-00029
• 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: 05/05/2014

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: Other
• Device Catalogue Number: 200290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/14/2014
• 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