MAUDE Adverse Event Report: JIANGSU WONDERFUL NONWOVEN TECH. CO., LTD COVERALLS ELASTIC CUFF & ANKLE 2XL WHT; NON-SURGICAL ISOLATION GOWN

Model Number	2202CV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the supplier investigation the device history record review did not indicate any exception that could lead to the reported incident.No sample was available for investigation.According to the supplier, the finished products meet the requirements of cardinal health and all inspections are within specification limits.Test results of the (b)(6) meet the specification requirements and no deviation was found during the manufacturing process.From the investigation, the root cause for the reported incident could not be determined.At this time no additional action will be taken but we will continue to monitor the trend of this type of incident.
Event or Problem Description
An employee reported an allergic reaction to the exterior of the white coveralls.She was sent to her allergy md on (b)(6) 2019.

• Brand Name: COVERALLS ELASTIC CUFF & ANKLE 2XL WHT
• Common Device Name: NON-SURGICAL ISOLATION GOWN
• Manufacturer (Section D): JIANGSU WONDERFUL NONWOVEN TECH. CO., LTD; 302 beijing east rd siyang,; suqian city, jiangsu 22370 0; CH 223700
• MDR Report Key: 8552034
• Report Number: 1423537-2019-00312
• Device Sequence Number: 13889186
• Product Code: OEA
• UDI-Device Identifier: 10885380125515
• UDI-Public: 10885380125515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/25/2019
• Report Date (Section F): 04/09/2019

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
• Operator of Device: No Information
• Device Model Number: 2202CV
• Device Catalogue Number: 2202CV
• Device Lot Number: 18KFPNA033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2019
• Date Report to Manufacturer: 04/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other