MAUDE Adverse Event Report: SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. KROGER; NON ADHESIVE STERILE PAD

Model Number UPC011110351227

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2015 aso was unable to receive information from customer as the end user did not provide any contact information or lot number so aso could contact the manufacturer.Aso reviewed satisfactory biocompatibility reports on products manufactured with the same materials.Refer to report for details.Upon review of customer complaint database aso concluded that there is no history of complaints for this type of product.Aso will monitor complaint database for trends.End user did not provide information.

Event Description

End user has reported that device stuck to his wound.Non stick portion of device is sticking to his wound.

• Brand Name: KROGER
• Type of Device: NON ADHESIVE STERILE PAD
• Manufacturer (Section D): SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO.; no.18, zhihe dong road; suzhou industrial park; suzhou, jiangsu 21512 2; CH 215122
• 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: 5287529
• MDR Text Key: 33227135
• Report Number: 1038758-2015-00112
• 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
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC011110351227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/19/2015
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1