MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE - CCDS SITE CCDS CRITICAL CARE DECONTAMINATION SYSTEM; DECONTAMINATION SYSTEM FOR RESPIRATORS

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

A battelle critical care decontamination system (ccds) worker reported an allergic reaction on both arms.The worker was loading the ccds chamber and noticed their arms were covered in hives after removing the tyvek jacket.After decon showered the hives were slightly worse.The worker went to er as a precaution.The er doctor confirmed it was an allergic reaction and gave medication and a cream.This report is required under the terms of the battelle ccds eua.All information known or reasonably known to battelle has been included in this submission.

Event Description

A battelle critical care decontamination system (ccds) worker reported an allergic reaction on both arms while loading teh ccds chamber.The er doctor confirmed it is an allergic reaction and gave medication and a cream.

• Brand Name: CCDS CRITICAL CARE DECONTAMINATION SYSTEM
• Type of Device: DECONTAMINATION SYSTEM FOR RESPIRATORS
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE - CCDS SITE; baltimore MD
• Manufacturer (Section G): CCDS SITE; baltimore MD
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11485869
• MDR Text Key: 239815802
• Report Number: 1523658-2021-00103
• Device Sequence Number: 1
• Product Code: QKY
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other