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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dermatome
Product CodeGFD
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 472 472
2020 433 433
2021 614 614
2022 545 545
2023 810 810
2024 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1066 1066
Power Problem 381 381
Unstable 338 338
Patient Device Interaction Problem 248 248
Intermittent Loss of Power 243 243
Gas/Air Leak 212 212
Appropriate Term/Code Not Available 169 169
Material Frayed 155 155
Calibration Problem 132 132
Mechanical Problem 109 109
Component Missing 85 85
Noise, Audible 82 82
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Material Deformation 76 76
Failure to Power Up 75 75
Loss of Power 69 69
Output Problem 63 63
Naturally Worn 61 61
Corroded 57 57
Break 51 51
Insufficient Information 51 51
Loose or Intermittent Connection 48 48
Physical Resistance/Sticking 48 48
Fitting Problem 45 45
Electrical /Electronic Property Problem 42 42
Adverse Event Without Identified Device or Use Problem 32 32
Incorrect Measurement 31 31
Output below Specifications 30 30
Positioning Problem 24 24
Material Integrity Problem 23 23
Structural Problem 22 22
Material Twisted/Bent 21 21
Material Split, Cut or Torn 20 20
Vibration 19 19
Electrical Power Problem 14 14
Detachment of Device or Device Component 14 14
Dull, Blunt 13 13
Overheating of Device 11 11
Pressure Problem 10 10
Activation Problem 10 10
Fluid/Blood Leak 8 8
Unexpected Shutdown 7 7
Failure to Calibrate 7 7
Degraded 7 7
Misassembled 6 6
Connection Problem 6 6
Complete Loss of Power 6 6
Failure to Shut Off 5 5
Defective Device 5 5
Mechanical Jam 5 5
Electrical Shorting 5 5
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Defective Component 4 4
Material Puncture/Hole 4 4
Excessive Heating 4 4
Temperature Problem 4 4
Improper Flow or Infusion 3 3
Device Damaged Prior to Use 3 3
Leak/Splash 3 3
Positioning Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output above Specifications 3 3
Circuit Failure 3 3
Difficult to Remove 3 3
Unexpected Therapeutic Results 2 2
Delivered as Unsterile Product 2 2
Unintended Power Up 2 2
Difficult to Open or Close 2 2
Off-Label Use 2 2
Misassembly by Users 2 2
Expulsion 2 2
Failure to Disconnect 2 2
Malposition of Device 2 2
Imprecision 2 2
Mechanics Altered 2 2
Gel Leak 2 2
Device Slipped 1 1
Packaging Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Flaked 1 1
Audible Prompt/Feedback Problem 1 1
Difficult to Insert 1 1
Thermal Decomposition of Device 1 1
Restricted Flow rate 1 1
Device Markings/Labelling Problem 1 1
Unclear Information 1 1
Device Handling Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Too Rigid or Stiff 1 1
Device Emits Odor 1 1
Failure to Clean Adequately 1 1
Unintended Movement 1 1
Inadequacy of Device Shape and/or Size 1 1
Obstruction of Flow 1 1
Smoking 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Deliver 1 1
Explosion 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1842 1842
No Patient Involvement 332 332
No Consequences Or Impact To Patient 263 263
Laceration(s) 223 223
No Known Impact Or Consequence To Patient 219 219
Abrasion 175 175
Insufficient Information 67 67
Unspecified Tissue Injury 42 42
No Code Available 42 42
Scar Tissue 15 15
Injury 15 15
Localized Skin Lesion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Skin Tears 5 5
Physical Asymmetry 4 4
Muscle/Tendon Damage 4 4
No Information 3 3
Suture Abrasion 3 3
Burn(s) 3 3
Scarring 2 2
Tissue Damage 2 2
Failure of Implant 2 2
Impaired Healing 2 2
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Sedation 1 1
Wrinkling 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Pain 1 1
Crushing Injury 1 1
Hematoma 1 1
Adhesion(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Sep-12-2020
2 Zimmer Surgical Inc II Oct-06-2023
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