MAUDE Adverse Event Report: SINNING INDUSTRIAL CO. LTD. ACE (TM) HINHED KNEE BRACE; 890.3475 LIMB ORTHOSIS

Catalog Number 209600

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

Patient Problem Irritation (1941)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Customer wore for a couple of hours in the morning.This was the first time for the customer to wear this brace.When the brace was removed there was a skin reaction in the area of the knee and calf.The next day the customer went to a doctor regarding the skin reaction.The doctor gave the customer medication.

Manufacturer Narrative

Manufacturing name and address should be considered confidential.

• Brand Name: ACE (TM) HINHED KNEE BRACE
• Type of Device: 890.3475 LIMB ORTHOSIS
• Manufacturer (Section D): SINNING INDUSTRIAL CO. LTD.; sha jing keng industrial zone; fu shan dist; liao bu, don guan, guangdong ; CH
• Manufacturer (Section G): WINNING INDUSTRIAL 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: 4186043
• MDR Text Key: 5024225
• Report Number: 2110898-2014-00068
• 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: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 209600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2014
• 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