MAUDE Adverse Event Report: ASO LLC CVS - HEAVY DUTY ANTI-BACTERIAL WATERPROOF BANDAGES 1 IN 15CT; ADHESIVE BANDAGES

Model Number 050428356821

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Scar Tissue (2060)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

Package labeling indicates that the bandages have a medicated pad with the active ingredient - benzalkonium chloride 0.1%.Package labeling discloses the product has a super-stick adhesive; not intended for use on delicate or sensitive skin.Aso/manufacturer reached out to consumer/end user on 2 occasions to request samples of the remaining device/product by return mail for investigation and testing; as of 09/29/2015, the consumer/user is planning to return the purchased device/product for aso investigation and testing.Device evaluated by manufacturer: evaluation of a representative sample of the related medical device is summarized.

Event Description

On 09/02/2015 (re: initial reporter) : consumer/end user reported using an antibacterial 1-inch bandage overnight.When removing the bandage the next morning, the bandage tore the skin, caused an abrasion on both sides, and left scarring.

Manufacturer Narrative

Aso received returned product from consumer on (b)(6) 2015.Aso lab tested returned product as well as retained product of the same lot for adhesion properties in (b)(6) 2015.Lab results were satisfactory with no defects found.

• Brand Name: CVS - HEAVY DUTY ANTI-BACTERIAL WATERPROOF BANDAGES 1 IN 15CT
• 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 ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5124613
• MDR Text Key: 27373581
• Report Number: 1038758-2015-00080
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00050428356821
• UDI-Public: 050428356821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/04/2015

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: Lay User/Patient
• Device Expiration Date: 01/22/2020
• Device Model Number: 050428356821
• Device Catalogue Number: 731231
• Device Lot Number: 24513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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