MAUDE Adverse Event Report: JIANGSU NANFANG MEDICAL CO. LTD. TOPCO; WATERPROOF TAPE 1/2IN. X 10 YDS.

Model Number UPC036800186002

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

Patient Problems Abrasion (1689); Scar Tissue (2060)

Event Date 12/05/2015

Event Type  Injury  

Manufacturer Narrative

As of 1/14/2016 aso has not obtained returned samples or a lot number from the consumer.However, aso has reviewed the complaint database to look for previous complaints with this device and there have not been any adverse events reported prior to this one.In addition, aso has obtained reports for the shipment history for the device from october 6, 2015 to november 18, 2015.The tests performed for adhesion to steel are acceptable.Aso has reviewed results of biocompatibility tests as well.

Event Description

Consumer reported that she used the device for the first time on (b)(6) 2015 and reapplied it daily until (b)(6) 2015 when she had a painful blistering reaction on her back.Consumer was prescribed a topical medication by dermatologist office.

• Brand Name: TOPCO
• Type of Device: WATERPROOF TAPE 1/2IN. X 10 YDS.
• 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 ; 9413790300
• MDR Report Key: 5368270
• MDR Text Key: 36010084
• Report Number: 1038758-2016-00004
• 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: 12/15/2015

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 Model Number: UPC036800186002
• Device Catalogue Number: 003680010711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2015
• Event Location: Home
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1