MAUDE Adverse Event Report: ASO LLC CVS HEALTH; SHEER BANDAGES ASSORTED SIZES

Model Number UPC#050428421918

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on (b)(6) 2019 medical treatment was required.Based on the information received, aso opted to file an mdr.As of (b)(6) 2019 aso evaluated unused retained samples from the same family of products from other lot/batch for adhesion properties, without defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening report.

Event Description

On the initial report on (b)(6) 2019 consumer states that even when the box said "not made with natural rubber latex", everywhere the bandage adhesive touched her skin she had a rash.On (b)(6) 2019 reporter stated on returned cir that she sought medical attention.

• Brand Name: CVS HEALTH
• Type of Device: SHEER BANDAGES ASSORTED SIZES
• 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
• MDR Report Key: 9131772
• MDR Text Key: 161696580
• Report Number: 1038758-2019-00042
• 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
• Report Date: 08/04/2019

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 Model Number: UPC#050428421918
• Device Catalogue Number: 702514
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other