MAUDE Adverse Event Report: SHANDONG SINCERE MEDICAL PRODUCTS CO., LTD. CVS PHARMACY; ELASTIC STRETCH NET

Model Number UPC#050428266540

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

Patient Problem Rash (2033)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

As of 11/14/2017 aso reviewed records for physical properties performed on pre-shipment samples of the same lot number with results acceptable in addition to evaluate the biocompatibility studies and latex screening.Complaint database was reviewed; there was no negative trend identified for the associated product.Trending is completed on all products monthly.

Event Description

Consumer stated that product caused her blisters and rash around the area where she had a biopsy.Consumer asked if the product contains latex.

• Brand Name: CVS PHARMACY
• Type of Device: ELASTIC STRETCH NET
• Manufacturer (Section D): SHANDONG SINCERE MEDICAL PRODUCTS CO., LTD.; 168 weixu road, jingzhi town,; anqui, shandong province 26210 0; CH 262100
• 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: 7042559
• MDR Text Key: 92373108
• Report Number: 1038758-2017-00044
• Device Sequence Number: 1
• Product Code: FQM
• 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: 10/30/2017,10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/04/2018
• Device Model Number: UPC#050428266540
• Device Catalogue Number: 894117
• Device Lot Number: 3099-100812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 10/30/2017
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2013
• 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