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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
Regulation Description Nonabsorbable gauze for internal use.
Product CodeGDY
Regulation Number 878.4450
Device Class 1

MDR Year MDR Reports MDR Events
2020 116 127
2021 134 185
2022 226 235
2023 98 98
2024 114 128
2025 97 103

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 193 193
Material Fragmentation 184 186
Material Frayed 159 246
Component Missing 50 50
Material Separation 39 50
Material Disintegration 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Material Integrity Problem 14 14
Device Misassembled During Manufacturing /Shipping 13 13
Delivered as Unsterile Product 12 16
Contamination 12 12
Contamination /Decontamination Problem 12 12
Packaging Problem 11 11
Incorrect Measurement 9 9
Material Split, Cut or Torn 8 8
Break 8 8
Entrapment of Device 7 7
Defective Device 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Device Contaminated During Manufacture or Shipping 5 5
Unraveled Material 5 5
Nonstandard Device 5 5
Product Quality Problem 4 4
Physical Resistance/Sticking 4 4
False Negative Result 3 3
Incomplete or Missing Packaging 3 3
Particulates 3 3
Insufficient Information 3 3
Component Misassembled 3 3
No Apparent Adverse Event 2 2
Illegible Information 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Component 2 2
Device Damaged Prior to Use 2 2
Separation Problem 2 2
Device Slipped 2 4
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Component Incompatible 1 1
False Positive Result 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Material Protrusion/Extrusion 1 1
Device Displays Incorrect Message 1 1
Lens (IOL), defective, problem not specified 1 1
Mechanical Jam 1 1
Fluid/Blood Leak 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 574 663
Insufficient Information 92 94
Foreign Body In Patient 52 52
No Consequences Or Impact To Patient 46 46
No Patient Involvement 19 19
No Known Impact Or Consequence To Patient 18 18
Device Embedded In Tissue or Plaque 7 7
Unintended Radiation Exposure 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Information 4 4
Hemorrhage/Bleeding 4 4
Unspecified Infection 1 1
Inflammation 1 1
Urinary Retention 1 1
Laceration(s) 1 1
Skin Tears 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 Carefree Surgical Specialties II Aug-08-2025
4 Covidien II Mar-21-2024
5 Cypress Medical Products LLC II Sep-14-2021
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