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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE; RESPIRATOR, DECONTAMINATED
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BATTELLE MEMORIAL INSTITUTE; RESPIRATOR, DECONTAMINATED Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Too Soft/Flexible (4007)
Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Event Date 10/28/2020
Event Type  malfunction  
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.Any blank fields indicate that information was unavailable.
 
Event Description
User reported burning sensation on face and mask appeared "floppy".The masks associated with this event were decontaminated with the battelle ccds "closed system" process.
 
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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 Key10829588
MDR Text Key228350923
Report Number1523658-2020-00208
Device Sequence Number1
Product Code QKY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age40 YR
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