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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device gauze/sponge, internal, x-ray detectable
Product CodeGDY
Regulation Number 878.4450
Device Class 1

MDR Year MDR Reports MDR Events
2017 252 252
2018 250 250
2019 177 179
2020 116 116
2021 133 182
2022 35 39

Device Problems MDRs with this Device Problem Events in those MDRs
Material Frayed 228 283
Material Fragmentation 176 176
Incomplete or Missing Packaging 79 79
Material Separation 78 78
Detachment of Device or Device Component 68 68
Packaging Problem 66 66
Component Missing 58 58
Particulates 34 34
Detachment Of Device Component 27 27
Material Disintegration 22 22
Material Integrity Problem 22 22
Device Contamination with Chemical or Other Material 16 16
Contamination /Decontamination Problem 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Appropriate Term/Code Not Available 12 12
Device Packaging Compromised 12 12
Break 12 12
Unraveled Material 11 11
Contamination 10 10
Flaked 7 7
Product Quality Problem 7 7
Nonstandard Device 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Physical Resistance/Sticking 7 7
Material Split, Cut or Torn 6 6
Delivered as Unsterile Product 6 6
Entrapment of Device 6 6
Defective Component 5 5
Defective Device 4 4
Fluid Leak 4 4
Disassembly 3 3
Material Discolored 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Dislodged or Dislocated 2 2
Separation Problem 2 2
Component Misassembled 2 2
Therapeutic or Diagnostic Output Failure 2 2
Explanted 2 2
False Negative Result 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Melted 2 2
Device Slipped 1 1
Problem with Sterilization 1 1
Lens (IOL), defective, problem not specified 1 1
Separation Failure 1 1
Microbial Contamination of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Foreign material 1 1
Kinked 1 1
Disconnection 1 1
No Display/Image 1 1
Component Falling 1 1
Torn Material 1 1
Insufficient Information 1 1
Protective Measures Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Device Fell 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Compatibility Problem 1 1
Output Problem 1 1
Mechanical Jam 1 1
Device Sensing Problem 1 1
Device Operates Differently Than Expected 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 266 267
No Known Impact Or Consequence To Patient 239 240
No Clinical Signs, Symptoms or Conditions 147 200
No Patient Involvement 143 143
No Information 114 114
Insufficient Information 42 42
Foreign Body In Patient 33 33
Device Embedded In Tissue or Plaque 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unintended Radiation Exposure 3 3
Not Applicable 2 2
Skin Irritation 2 2
Injury 2 2
Skin Tears 2 2
Burn, Thermal 1 1
Blood Loss 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Hyperbilirubinemia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Radiation Exposure, Unintended 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Feb-04-2022
2 Argon Medical Devices, Inc II May-08-2020
3 Covidien LLC II Mar-19-2018
4 Covidien LP II Feb-08-2018
5 Cypress Medical Products LLC II Sep-14-2021
6 Medical Action Industries Inc II Mar-28-2019
7 Medical Action Industries Inc II Dec-22-2018
8 Medical Action Industries Inc II May-17-2017
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