MAUDE Adverse Event Report: ASO LLC WALGREENS WOUND CLOSURE ADHESIVE STRIPS

Model Number 311917143354

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

Patient Problems Rash (2033); Burning Sensation (2146); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

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; to date there has been no response.Device evaluated by manufacturer.Evaluation of a representative sample of the related medical device is summarized.

Event Description

On (b)(6) 2015 consumer/end-user reported that the wound closure strips left a bad rash, tore the skin off, and burned the skin.

• Brand Name: WALGREENS WOUND CLOSURE ADHESIVE STRIPS
• Type of Device: ADHESIVE STRIPS
• 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: 5219109
• MDR Text Key: 30969586
• Report Number: 1038758-2015-00083
• Device Sequence Number: 1
• Product Code: FPX
• UDI-Device Identifier: 00311917143354
• UDI-Public: 311917143354
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2020
• Device Model Number: 311917143354
• Device Catalogue Number: 156744
• Device Lot Number: 00031936
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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