MAUDE Adverse Event Report: YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD. CVS HEALTH; STERILE PADS 4X4 IN

Model Number UPC#050428367988

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

Patient Problem Skin Irritation (2076)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

As of 10/02/2017 aso did not receive information from the consumer on this lot number and has notified the manufacturer.Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.

Event Description

Consumer stated that he noticed that one of the items had a grayish-black spot on it.He used an item without the spot and he stated that his wound has gotten worse.

Manufacturer Narrative

As of 10/02/2017 aso did not receive information from the consumer on this lot number and has notified the manufacturer.Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.As of 12/18/2017 aso received completed cir from the consumer with confirmation of the lot number.Aso reviewed records for absorbency on pre-shipment samples and performed absorption capacity on unused returned product.Refer for further details.The following sections were updated: correction on the upc number and lot number added.Correction - product is not labeled for single use.(b)(4).

Event Description

Consumer stated that he noticed that one of the items had a grayish-black spot on it.He used an item without the spot and he stated that his wound has gotten worse.

• Brand Name: CVS HEALTH
• Type of Device: STERILE PADS 4X4 IN
• Manufacturer (Section D): YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD.; 18 south xishan rd; chenji town, yizheng jiangsu 21140 8; CH 211408
• 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: 6913617
• MDR Text Key: 88128777
• Report Number: 1038758-2017-00032
• Device Sequence Number: 1
• Product Code: NAB
• 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: 09/21/2017,09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#050428367988
• Device Catalogue Number: 895760
• Device Lot Number: 2384-20161215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 09/21/2017
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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