MAUDE Adverse Event Report: SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. CVS HEALTH; NON-STICK PADS

Model Number UPC#050428307274

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

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

As of 12/13/2019 no returned samples were received from consumer.As no lot number was provided manufacturer is unable to evaluate retained product samples.Aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.

Event Description

On the initial report of 11/25/2019 consumer stated that product was stuck in her wound and tore the scab upon removal, she stated she would seek medical attention.

• Brand Name: CVS HEALTH
• Type of Device: NON-STICK PADS
• Manufacturer (Section D): SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO.; no.18, zhihe dong road; suzhou industrial park; suzhou, 21512 2; CH 215122
• 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: 9521093
• MDR Text Key: 188562400
• Report Number: 1038758-2019-00058
• Device Sequence Number: 1
• Product Code: NAC
• 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: 11/26/2019,11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#050428307274
• Device Catalogue Number: 935683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 11/26/2019
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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