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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device marker, skin
Regulation Description Skin marker.
Product CodeFZZ
Regulation Number 878.4660
Device Class 1

MDR Year MDR Reports MDR Events
2016 19 19
2017 24 24
2018 21 21
2019 18 18
2020 14 14
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 19 19
Defective Component 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Defective Device 12 12
Leak/Splash 12 12
Packaging Problem 9 9
Device Packaging Compromised 9 9
Improper or Incorrect Procedure or Method 4 4
Break 3 3
Detachment of Device or Device Component 3 3
Off-Label Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Operates Differently Than Expected 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Torn Material 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Detachment Of Device Component 1 1
Fluid Leak 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Device Markings/Labelling Problem 1 1
Out-Of-Box Failure 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Chemical Spillage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34 34
No Patient Involvement 20 20
No Clinical Signs, Symptoms or Conditions 14 14
No Information 9 9
Edema 9 9
Pain 6 6
No Consequences Or Impact To Patient 6 6
Necrosis 5 5
Unspecified Infection 5 5
Inflammation 4 4
Abscess 4 4
Numbness 3 3
Skin Irritation 2 2
Swelling 2 2
Insufficient Information 2 2
Abrasion 2 2
Ecchymosis 2 2
Nerve Damage 2 2
Renal Failure 1 1
Sepsis 1 1
Itching Sensation 1 1
Anemia 1 1
Autoimmune Disorder 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Erythema 1 1
Eye Injury 1 1
Fever 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Swollen Lymph Nodes 1 1
Ulceration 1 1
Sleep Dysfunction 1 1
Chemical Exposure 1 1
Complaint, Ill-Defined 1 1
Malaise 1 1

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