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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
2017 446 446
2018 480 480
2019 468 468
2020 486 486
2021 554 554

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1387 1387
Material Twisted/Bent 524 524
Bent 156 156
Physical Resistance/Sticking 131 131
Device Operates Differently Than Expected 110 110
Mechanical Jam 99 99
Difficult to Remove 54 54
Mechanical Problem 51 51
Material Deformation 30 30
Break 29 29
Appropriate Term/Code Not Available 20 20
Component Missing 19 19
Dull, Blunt 18 18
Difficult to Advance 18 18
Naturally Worn 17 17
Patient Device Interaction Problem 13 13
Device Contaminated During Manufacture or Shipping 11 11
Output Problem 11 11
Device Damaged Prior to Use 11 11
Sticking 11 11
Material Too Rigid or Stiff 8 8
Calibration Problem 8 8
Difficult to Open or Close 7 7
Material Split, Cut or Torn 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Expiration Date Error 5 5
Fitting Problem 5 5
Defective Component 5 5
Fracture 5 5
Difficult To Position 4 4
Defective Device 4 4
Mechanics Altered 4 4
Material Integrity Problem 3 3
Dent in Material 3 3
Failure to Align 3 3
Device Contamination with Chemical or Other Material 3 3
Activation, Positioning or SeparationProblem 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Incorrect Measurement 3 3
Device Slipped 3 3
Corroded 3 3
Disassembly 3 3
Insufficient Information 3 3
Crack 2 2
Positioning Failure 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Loss of Power 2 2
Metal Shedding Debris 2 2
Detachment of Device or Device Component 2 2
Contamination /Decontamination Problem 2 2
Failure to Advance 2 2
Separation Failure 2 2
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Wrinkled 1 1
Failure to Disconnect 1 1
Connection Problem 1 1
Free or Unrestricted Flow 1 1
Gas Leak 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Cut In Material 1 1
Inadequacy of Device Shape and/or Size 1 1
No Device Output 1 1
Peeled/Delaminated 1 1
Misassembled 1 1
Difficult to Insert 1 1
Degraded 1 1
Material Discolored 1 1
Flaked 1 1
Detachment Of Device Component 1 1
Partial Blockage 1 1
Operating System Becomes Nonfunctional 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Ejection Problem 1 1
Activation Problem 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 778 778
No Patient Involvement 603 603
No Known Impact Or Consequence To Patient 499 499
No Clinical Signs, Symptoms or Conditions 493 493
Abrasion 79 79
No Information 43 43
No Code Available 39 39
Insufficient Information 24 24
Laceration(s) 15 15
Injury 5 5
Tissue Damage 5 5
Skin Tears 1 1
Oversedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Molnlycke Health Care, Inc II May-03-2017
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