MAUDE Adverse Event Report: DANYANG SUNMED HEALTHCARE CORPORATION WALGREENS; FOAM TAPE

Model Number UPC#311917205465

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 03/21/2023

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 03/21/2023 consumer stated medical tratment was sought.Based on the information received, aso opted to file an mdr.As of 04/05/2023 unused returned product were submitted to the lab for testing with no defects noted.Also manufacturer evaluated retained samples of the same lot with no defects noted.In addition, aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.

Event Description

On the initial report received by aso on 02/20/2023 consumer stated that when she removed the product, she immediately felt pain and warm liquid and was blood.The product tore the skin from her left breast upon removal.On the completed cir received from the consumer on 03/21/2023, she stated that she used the product to hold a gauze pad, and when she removed the product, it took a piece of her skin, and she started to bleed.The consumer went to an appointment with her primary dr.And showed the wound.Dr.Told her to use saline wash and peroxide and clean the area.The consumer stated that the symptoms were corrected after stopping using the product.

• Brand Name: WALGREENS
• Type of Device: FOAM TAPE
• Manufacturer (Section D): DANYANG SUNMED HEALTHCARE CORPORATION; no.3 bei er huan; danyang, jiangsu ; CH
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL
• MDR Report Key: 16744129
• MDR Text Key: 313338383
• Report Number: 1038758-2023-00007
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2023

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: Lay User/Patient
• Device Model Number: UPC#311917205465
• Device Lot Number: 2423-21164
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2021
• 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
• Patient Sex: Female