MAUDE Adverse Event Report: SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. CVS; NON ADHERENT DRESSINGS

Model Number UPC50428466148

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

As of 12/04/2015 aso has not received lot number or product return from consumer.Aso has sent letters to the consumer on 11/06/2015 and 11/24/2015.A third letter was sent to the consumer on 12/4/2015.Aso has not contacted the manufacturer of product as we currently don't have any information on lot number or samples.Consumer has not provided information.

Event Description

End user claims she purchased device for her husband.Applied device 5 days after incident.After healing was well underway, device stuck to the wound and reopened them.

Manufacturer Narrative

Aso is pending the manufacturer's investigation.

Manufacturer Narrative

Aso tested returned samples for absorbency on 03/03/2016.

• Brand Name: CVS
• Type of Device: NON ADHERENT DRESSINGS
• 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: 5272297
• MDR Text Key: 32863609
• Report Number: 1038758-2015-00108
• 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,Followup
• Report Date: 01/27/2016,11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC50428466148
• Device Catalogue Number: 752877
• Device Lot Number: 2384-2015501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/05/2015
• Date Report to Manufacturer: 01/27/2016
• Was Device Evaluated by Manufacturer?: No
• 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