MAUDE Adverse Event Report: JIANGSU NANFANG MEDICAL CO. LTD. CVS HEALTH; WATERPROOF ADHESIVE TAPE

Model Number UPC#050428269084

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

Patient Problems Abrasion (1689); Skin Irritation (2076); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2019 unused samples or lot number were not provided.Aso has reviewed records of biocompatibility tests and notified the manufacturer about the event.

Event Description

On the initial report on (b)(6) 2019 consumer stated the tape caused him itching, burning sensation and abrasion.He also added that upon removal he had an infection in the area.On (b)(6) 2019 consumer informed he sought medical attention.

• Brand Name: CVS HEALTH
• Type of Device: WATERPROOF ADHESIVE TAPE
• Manufacturer (Section D): JIANGSU NANFANG MEDICAL CO. LTD.; no. 1 guoxiang rd. wujin; economic development zone; wujin, changzhou, 21314 9; CH 213149
• 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: 9168740
• MDR Text Key: 161809333
• Report Number: 1038758-2019-00044
• 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: 09/13/2019,09/08/2019

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#050428269084
• Device Catalogue Number: 964607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2019
• Date Report to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 09/08/2019
• Initial Date FDA Received: 10/08/2019
• 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