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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 30 31

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 210 210
Detachment of Device or Device Component 184 184
Material Frayed 145 205
Component Missing 62 62
Material Separation 38 38
Contamination /Decontamination Problem 14 14
Material Disintegration 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Material Integrity Problem 14 14
Packaging Problem 13 13
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
Material Split, Cut or Torn 7 7
Adverse Event Without Identified Device or Use Problem 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
Device Contamination with Chemical or Other Material 5 5
Device Contaminated During Manufacture or Shipping 5 5
Physical Resistance/Sticking 5 5
Fluid/Blood Leak 4 4
Component Misassembled 3 3
Patient Device Interaction Problem 2 2
Separation 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
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 417 476
No Consequences Or Impact To Patient 128 129
Insufficient Information 76 76
No Known Impact Or Consequence To Patient 57 58
No Patient Involvement 55 55
Foreign Body In Patient 39 39
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 Covidien II Mar-21-2024
4 Cypress Medical Products LLC II Sep-14-2021
5 Medical Action Industries Inc II Mar-28-2019
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