MAUDE Adverse Event Report: DEROYAL INDUSTRIAL KNEE SUPPORT, W/ BUTTRESS, MED/LAT STAYS, XL

Catalog Number NE7718-75

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

Patient Problem Asthma (1726)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

The customer states that the braces have a very strong odor that is affecting her asthma so she can't wear them.

Manufacturer Narrative

Investigation findings: the complaint sample was returned.Upon opening the boxes, the only smell i noted is the smell of the neoprene and the chemicals (b-foam and cr adhesive) that the material is made of.It is normal for neoprene to have a "smell." this appears to have been an irritant to the customer's asthma issues.I have attached an email from the customer regarding the complaint and issues reported by their customer.Correction: credit requested.Root cause analysis: the customer's sensitivity to the materials used to make neoprene have created an eye/breathing irritant.Corrective action and/or systemic correction action taken: no action required at this time, no manufacturing issue was found.The complaint is related to the customer's personal sensitivities.

• Brand Name: KNEE SUPPORT, W/ BUTTRESS, MED/LAT STAYS, XL
• Manufacturer (Section D): DEROYAL INDUSTRIAL; 64 giles hollow road; rose hill VA 24281
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 3812565
• MDR Text Key: 4528542
• Report Number: 1123071-2014-00006
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NE7718-75
• Device Lot Number: 35423214
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2014
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention