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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
2018 250 250
2019 177 179
2020 116 116
2021 133 182
2022 226 235
2023 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 208 208
Material Frayed 206 265
Detachment of Device or Device Component 191 191
Material Separation 74 74
Component Missing 62 62
Incomplete or Missing Packaging 42 42
Packaging Problem 42 42
Material Integrity Problem 18 18
Device Misassembled During Manufacturing /Shipping 17 17
Particulates 17 17
Material Disintegration 16 16
Contamination /Decontamination Problem 16 16
Manufacturing, Packaging or Shipping Problem 13 13
Contamination 13 13
Break 12 12
Detachment Of Device Component 11 11
Device Contamination with Chemical or Other Material 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Incorrect Measurement 9 9
Product Quality Problem 8 8
Nonstandard Device 8 8
Delivered as Unsterile Product 8 9
Unraveled Material 8 8
Appropriate Term/Code Not Available 8 8
Material Split, Cut or Torn 7 7
Physical Resistance/Sticking 7 7
Entrapment of Device 7 7
Device Contaminated During Manufacture or Shipping 5 5
Defective Device 5 5
Fluid/Blood Leak 4 4
False Negative Result 3 3
Material Discolored 3 3
Flaked 3 3
Component Misassembled 3 3
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Melted 2 2
Device Slipped 2 2
Defective Component 2 2
Microbial Contamination of Device 1 1
Separation Failure 1 1
Problem with Sterilization 1 1
Improper or Incorrect Procedure or Method 1 1
Disconnection 1 1
No Display/Image 1 1
Component Falling 1 1
Component Incompatible 1 1
Fire 1 1
Explanted 1 1
Foreign material 1 1
Kinked 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Protective Measures Problem 1 1
Noise, Audible 1 1
Device Fell 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Device Displays Incorrect Message 1 1
Lens (IOL), defective, problem not specified 1 1
Device Markings/Labelling Problem 1 1
Device Packaging Compromised 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Compatibility Problem 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 378 436
No Consequences Or Impact To Patient 194 195
No Known Impact Or Consequence To Patient 176 177
No Information 77 77
No Patient Involvement 75 75
Insufficient Information 68 68
Foreign Body In Patient 42 42
Device Embedded In Tissue or Plaque 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unintended Radiation Exposure 4 4
Hemorrhage/Bleeding 4 4
Injury 2 2
Burn, Thermal 1 1
Blood Loss 1 1
Unspecified Infection 1 1
Inflammation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Abdominal Pain 1 1
Death 1 1
No Code Available 1 1
Radiation Exposure, Unintended 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
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