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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
2019 177 179
2020 116 116
2021 133 182
2022 226 235
2023 98 98
2024 18 19

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 205 205
Detachment of Device or Device Component 183 183
Material Frayed 144 204
Component Missing 62 62
Material Separation 38 38
Contamination /Decontamination Problem 14 14
Material Disintegration 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Packaging Problem 13 13
Material Integrity Problem 12 12
Contamination 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Break 9 9
Incorrect Measurement 8 8
Unraveled Material 8 8
Nonstandard Device 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Material Split, Cut or Torn 7 7
Delivered as Unsterile Product 6 7
Defective Device 6 6
Incomplete or Missing Packaging 5 5
Particulates 5 5
Product Quality Problem 5 5
Entrapment of Device 5 5
Physical Resistance/Sticking 5 5
Device Contamination with Chemical or Other Material 5 5
Device Contaminated During Manufacture or Shipping 5 5
Fluid/Blood Leak 4 4
Component Misassembled 3 3
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Melted 2 2
Material Discolored 2 2
Device Slipped 2 2
Defective Component 2 2
Device Markings/Labelling Problem 1 1
Separation Failure 1 1
Device Displays Incorrect Message 1 1
Lens (IOL), defective, problem not specified 1 1
Improper or Incorrect Procedure or Method 1 1
Unable to Obtain Readings 1 1
Disconnection 1 1
Component Incompatible 1 1
Explanted 1 1
False Negative Result 1 1
Fire 1 1
Misassembled 1 1
Loose or Intermittent Connection 1 1
Foreign material 1 1
No Display/Image 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Output Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 407 466
No Consequences Or Impact To Patient 128 129
Insufficient Information 75 75
No Known Impact Or Consequence To Patient 57 58
No Patient Involvement 55 55
Foreign Body In Patient 36 36
No Information 22 22
Device Embedded In Tissue or Plaque 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hemorrhage/Bleeding 4 4
Unintended Radiation Exposure 4 4
Unspecified Infection 1 1
Inflammation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Injury 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Blood Loss 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 Cypress Medical Products LLC II Sep-14-2021
4 Medical Action Industries Inc II Mar-28-2019
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