MAUDE Adverse Event Report: ASO LLC KROGER; HEAVY FABRIC STRONG STRIPS ANTIBACT

Model Number UPC: 041260341779

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 03/25/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the end user reported he covered a wound with the device and when the device was pulled off his skin, it left an outline on his skin, causing a skin wound.

Manufacturer Narrative

The printed box labeling indicates that the product has a super strength adhesive and is not intended for use on delicate or sensitive skin.Customer as of (b)(4) 2015 did not provide lot # or returned product.Cannot complete section 6.

• Brand Name: KROGER
• Type of Device: HEAVY FABRIC STRONG STRIPS ANTIBACT
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4817874
• MDR Text Key: 5921789
• Report Number: 1038758-2015-00022
• Device Sequence Number: 1
• Product Code: LWF
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC: 041260341779
• Device Catalogue Number: 91573346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1