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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrin sealant preparation device
Product CodeMZM
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 3
OMRIX BIOPHARMACEUTICALS LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2019 6 6
2020 38 38
2021 26 26
2022 103 103
2023 47 47
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 138 138
Appropriate Term/Code Not Available 64 64
Break 33 33
Material Separation 14 14
Material Integrity Problem 10 10
Connection Problem 7 7
Detachment of Device or Device Component 4 4
Device Markings/Labelling Problem 3 3
Device Operates Differently Than Expected 3 3
Difficult to Open or Close 3 3
Activation Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Component Missing 1 1
Failure to Align 1 1
Misfire 1 1
Separation Failure 1 1
Defective Device 1 1
Failure To Adhere Or Bond 1 1
Loss of or Failure to Bond 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Contamination 1 1
Material Discolored 1 1
Device Expiration Issue 1 1
Leak/Splash 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Activation, Positioning or Separation Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Patient Device Interaction Problem 1 1
Device Dislodged or Dislocated 1 1
Excessive Cooling 1 1
Failure of Device to Self-Test 1 1
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Material Too Soft/Flexible 1 1
Ejection Problem 1 1
Firing Problem 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 214 214
No Consequences Or Impact To Patient 29 29
Insufficient Information 6 6
Hemorrhage/Bleeding 2 2
Death 2 2
No Known Impact Or Consequence To Patient 1 1
Inadequate Pain Relief 1 1
Unspecified Infection 1 1

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