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

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Type  malfunction  

Manufacturer Narrative

Device not returned.Ccds staff has been in contact with hcp, explaining the decontamination process, the chemicals used (sdss), the potential issues with the fit and the odor, 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.

Event Description

User reported rash causing cystic acne and mask not sealing properly.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: 11386285
• MDR Text Key: 233795276
• Report Number: 1523658-2021-00091
• 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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