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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device expander, surgical, skin graft
Product CodeFZW
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 480 480
2019 468 468
2020 486 486
2021 554 554
2022 510 510
2023 494 494

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1677 1677
Material Twisted/Bent 692 692
Physical Resistance/Sticking 274 274
Appropriate Term/Code Not Available 124 124
Mechanical Jam 86 86
Material Deformation 82 82
Mechanical Problem 70 70
Bent 61 61
Naturally Worn 59 59
Difficult to Remove 47 47
Break 37 37
Dull, Blunt 30 30
Patient Device Interaction Problem 30 30
Calibration Problem 21 21
Insufficient Information 20 20
Component Missing 17 17
Material Integrity Problem 16 16
Device Operates Differently Than Expected 14 14
Output Problem 13 13
Difficult to Advance 13 13
Fitting Problem 12 12
Device Damaged Prior to Use 10 10
Activation, Positioning or Separation Problem 10 10
Material Too Rigid or Stiff 9 9
Positioning Problem 7 7
Material Split, Cut or Torn 7 7
Activation Failure 5 5
No Apparent Adverse Event 5 5
Difficult to Open or Close 5 5
Failure to Align 5 5
Expiration Date Error 5 5
Loose or Intermittent Connection 5 5
Defective Component 5 5
Degraded 5 5
Material Discolored 5 5
Electrical /Electronic Property Problem 4 4
Difficult To Position 4 4
Defective Device 4 4
Detachment of Device or Device Component 4 4
Dent in Material 4 4
Connection Problem 4 4
Packaging Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Activation Problem 4 4
Failure to Disconnect 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Slipped 3 3
Sticking 3 3
Disassembly 3 3
Misassembled 3 3
Corroded 3 3
Crack 2 2
Fracture 2 2
Structural Problem 2 2
Loss of Power 2 2
Incorrect Measurement 2 2
Failure to Advance 2 2
Contamination /Decontamination Problem 2 2
Failure to Clean Adequately 2 2
Illegible Information 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Ejection Problem 1 1
Device Handling Problem 1 1
Free or Unrestricted Flow 1 1
Gas/Air Leak 1 1
Operating System Becomes Nonfunctional 1 1
Mechanics Altered 1 1
Device Damaged by Another Device 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Failure to Power Up 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Labelling, Instructions for Use or Training Problem 1 1
Flaked 1 1
No Device Output 1 1
Peeled/Delaminated 1 1
Positioning Failure 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1479 1479
No Patient Involvement 597 597
No Consequences Or Impact To Patient 506 506
No Known Impact Or Consequence To Patient 353 353
Abrasion 70 70
Insufficient Information 34 34
No Code Available 31 31
No Information 24 24
Laceration(s) 21 21
Tissue Damage 5 5
Injury 4 4
Skin Tears 1 1
Oversedation 1 1

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