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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMO FISHER SCIENTIFIC FORMAL-FIXX FIXATIVE, FORMALIN-CONTAINING

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THERMO FISHER SCIENTIFIC FORMAL-FIXX FIXATIVE, FORMALIN-CONTAINING Back to Search Results
Catalog Number 9990914
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
The formalin biopsy specimen bottle covers are leaking on a daily basis. Covers are put on and double checked for a good seal because this has been happening continuously and daily. Formalin leaks and when bottles are checked to go to path the bottles are found to have leaked.
 
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Brand NameFORMAL-FIXX
Type of DeviceFIXATIVE, FORMALIN-CONTAINING
Manufacturer (Section D)
THERMO FISHER SCIENTIFIC
168 third avenue
waltham MA 02451
MDR Report Key11607400
MDR Text Key243563590
Report Number11607400
Device Sequence Number1
Product Code LDY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9990914
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2021
Event Location No Information
Date Report to Manufacturer04/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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