MAUDE Adverse Event Report: ASO LLC CVS; CVS WATERSHIELD ADHESIVE PAD 3X4

Model Number UPC050428455890

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

Patient Problem Abrasion (1689)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

Aso has received returned samples of the same lot number from the consumer on 01/07/2016 and will be reviewing those samples.However, aso has reviewed records of biocompatibility test data.

Event Description

End user reported that she noticed a rash around the device and when removing it, the device rip a piece of skin off.

Manufacturer Narrative

Aso has received samples of product returned by consumer.Aso has performed test for adhesion properties with no defects found.

• Brand Name: CVS
• Type of Device: CVS WATERSHIELD ADHESIVE PAD 3X4
• 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5352194
• MDR Text Key: 35303572
• Report Number: 1038758-2016-00001
• Device Sequence Number: 1
• Product Code: KGX
• 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,Followup
• Report Date: 12/08/2015

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
• Device Expiration Date: 03/28/2020
• Device Model Number: UPC050428455890
• Device Catalogue Number: 893124
• Device Lot Number: 27236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2015
• 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