MAUDE Adverse Event Report: WINNING INDUSTRIAL CO. LTD. WALGREEN'S BY ACE KNEE STABILIZER; 890.3475 LIMB ORTHOSIS

Catalog Number 201860

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

Patient Problem Irritation (1941)

Event Date 11/10/2014

Event Type  No Answer Provided  

Event Description

Per communications with the customer: customer wore the brace for a few hours.When he took the brace off, he had a rash from where the top of the brace was to the bottom of brace.Customer went to the doctor and was given a wrap to wear around the area.Says he was also given steroids to help with the swelling.

Manufacturer Narrative

Product was not returned to the manufacturer.Product was not returned for evaluation.No conclusion can be drawn.

• Brand Name: WALGREEN'S BY ACE KNEE STABILIZER
• Type of Device: 890.3475 LIMB ORTHOSIS
• Manufacturer (Section D): WINNING INDUSTRIAL CO. LTD.; sha jng keng industrial zone; fu shan dist.; liao bu, don guan, guangdong ; CH
• Manufacturer (Section G): WINNING INDUSTRIAL CO. LTD.; sha jng 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: 4368230
• MDR Text Key: 5236798
• Report Number: 2110898-2014-00076
• 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: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 201860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1