Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE N/A; RESPIRATOR, DECONTAMINATED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BATTELLE MEMORIAL INSTITUTE N/A; RESPIRATOR, DECONTAMINATED Back to Search Results
Device Problem Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device not returned.Ccds staff and hcp are in discussion providing additional information concerning the decontamination process and what could cause straps failing as well proved an faqs link.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 straps feel and look stretched out and there is concern with a proper seal.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
N/A
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 Key11181452
MDR Text Key239101651
Report Number1523658-2021-00046
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
-
-