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

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

Patient Problems Cellulitis (1768); Caustic/Chemical Burns (2549); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

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.Although no malfunction or serious injury of the decontaminated respirator has been confirmed, this report is required under the terms of the eua.All information known or reasonably known to battelle has been included in this submission.

Event Description

User reported wearing a respirator 1x/week for about 2 hours.On (b)(6) 2021, the employee donned a decontaminated respirator.She stated that it quickly felt "uncomfortable" on her face.It moved to painful.After about an hour she removed the respirator and found her nose and checks were red and starting to blister.She donned a new respirator.On (b)(6) 2021, employee reported that her face felt like it was burnt, red and small blisters.On (b)(6) 2021, her face started to swell, warm, red and painful.Employee went to a dr.And was diagnosed with cellulitis due to a chemical burn.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.

• Brand Name: NA
• Type of Device: RESPIRATOR, DECONTAMINATED
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE; 505 king ave; columbus OH 43201
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11386305
• MDR Text Key: 233808537
• Report Number: 1523658-2021-00102
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 02/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other