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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSTEX SPS MEDICAL HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST; BIOLOGICAL INDICATOR
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CROSSTEX SPS MEDICAL HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST; BIOLOGICAL INDICATOR Back to Search Results
Model Number IMS-1373
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
The facility reported a dental assistant was activating a biological indicator (bi) when the vial burst in their hand.There is the potential risk for user injury.The dental assistant did not allow the vial to cool for ten minutes or wear a face shield per the instructions for use (ifu).They did not report any exposure to the contents of the burst vial.There was no medical attention sought and they are reported to be doing fine.This will continue to be monitored in the crosstex sps medical complaint handling system.
 
Event Description
The facility reported a dental assistant was activating a biological indicator (bi) when the vial burst in their hand.There is the potential risk for user injury.
 
Manufacturer Narrative
The manufacturing address has been updated.
 
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Brand Name
HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST
Type of Device
BIOLOGICAL INDICATOR
Manufacturer (Section D)
CROSSTEX SPS MEDICAL
31 water street #1
cuba NY 14727
MDR Report Key8683867
MDR Text Key147498814
Report Number1319130-2019-00002
Device Sequence Number1
Product Code FRC
Combination Product (y/n)N
PMA/PMN Number
K111515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberIMS-1373
Device Catalogue NumberIMS-1373
Device Lot Number6761
Was Device Available for Evaluation? No
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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