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 Itching Sensation (1943); Burning Sensation (2146)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Battelle critical care decontamination system (ccds) worker reported contact with unknown substance and reported a burning and itching sensation, and temporary skin redness on their legs.During the ccds loading process, the ccds worker removed the inner bag from the outer bag of a box containing n95 respirators to be decontaminated.The inner bag came to rest against the workers legs.The bag was saturated with a clear, soapy liquid that saturated the worker's pants.The worker decon'ed and exited the chamber and immediately showered to wash the substance off of their skin.The irritation went away after the shower, however, an area of reddened skin remained for about two hours.No medical attention required.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

Battelle critical care decontamination system (ccds) worker reported contact with unknown substance and reported a burning and itching sensation, and temporary skin redness on their legs for about two hours.No medical attention required.

• 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: 11350055
• MDR Text Key: 239692139
• Report Number: 1523658-2021-00076
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 09/12/2020
• 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