MAUDE Adverse Event Report: ASO LLC EQUATE FABRIC ANTIBACTERIAL 200 CT VALUE BANDAGES; ADHESIVE BANDAGES

Device Problem Failure to Obtain Sample (2533)

Patient Problems Abrasion (1689); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: aso/ manufacturer reached out to consumer/end user on 3 occasions to request samples of the remaining device/product by return mail for investigation and testing; to date there has been no response.Additional data: per device evaluated by manufacturer - evaluation of a representative sample of the related medical device is summarized.

Event Description

Customer/end user reported that shortly after applying the bandage the adhesive part of the bandage caused a burning sensation and caused the skin to come off.The affected area became sore and left scabs in the shape of the bandage.No indication that medical treatment was sought.

Manufacturer Narrative

Aso lab evaluated returned samples on (b)(6) 2015 for adhesion properties with no defects observed with samples.

• Brand Name: EQUATE FABRIC ANTIBACTERIAL 200 CT VALUE BANDAGES
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: steve walter, vp ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5045197
• MDR Text Key: 24798689
• Report Number: 1038758-2015-00071
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Lay User/Patient
• Type of Report: Followup
• Report Date: 07/20/2015

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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