MAUDE Adverse Event Report: JIANGSU NANFANG MEDICAL CO. LTD. CVS/PHARMACY; EASY TEAR ADHESIVE TAPE

Model Number UPC#050428269084

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wheal(s) (2241)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2018 aso did not receive information from the consumer of the lot number and has notified the manufacturer.Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.It appears that the user used the tape incorrectly by using the tape directly on the wound.

Event Description

Customer reported that her husband used the product over two wounds.The product caused red bumps filled with water.

Manufacturer Narrative

As of 03/07/2018 aso did not receive information from the consumer of the lot number and has notified the manufacturer.Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.It appears that the user used the tape incorrectly by using the tape directly on the wound.As of 03/30/2018 consumer received completed cir and unused product.However, lot number could not be identified.Consumer stated that tape was applied to secure dressing, therefore correct intended use.Unused returned product was submitted to the lab for testing.(b)(4).

Event Description

Customer reported that her husband used the product over two wounds.The product caused red bumps filled with water.

• Brand Name: CVS/PHARMACY
• Type of Device: EASY TEAR 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: 7325341
• MDR Text Key: 101953592
• Report Number: 1038758-2018-00007
• 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: 03/07/2018,02/09/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2018
• Date Report to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 04/02/2018
• 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