MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE; RESPIRATOR, DECONTAMINATED

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

Patient Problems Rash (2033); Sneezing (2251); Cough (4457)

Event Type  malfunction  

Manufacturer Narrative

Although no malfunction or serious injury of the decontaminated respirator has been confirmed, this report is required under the terms of the eua.Ccds staff has been in contact with hcp, explaining the decontamination process, the chemicals used (sdss), and provided a link to faqs for hcps as well as suggesting airing out the masks prior to use.All information known or reasonably known to battelle has been included in this submission.

Event Description

User reported coughing, sneezing, runny nose, red rash around face.The mask associated with this event was decontaminated with the battelle ccds "closed system" process.

Manufacturer Narrative

Correction of product code from qla to qky based on fda feedback.

• Brand Name: NA
• Type of Device: RESPIRATOR, DECONTAMINATED
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE; 505 king ave; columbus OH 43201
• MDR Report Key: 10764059
• MDR Text Key: 213938705
• Report Number: 1523658-2020-00010
• Device Sequence Number: 1
• Product Code: QKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR