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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
2017 252 252
2018 250 250
2019 177 179
2020 116 116
2021 133 182
2022 200 209

Device Problems MDRs with this Device Problem Events in those MDRs
Material Frayed 243 302
Material Fragmentation 201 201
Detachment of Device or Device Component 178 178
Material Separation 80 80
Incomplete or Missing Packaging 79 79
Component Missing 66 66
Packaging Problem 66 66
Particulates 34 34
Detachment Of Device Component 27 27
Material Disintegration 23 23
Material Integrity Problem 22 22
Device Contamination with Chemical or Other Material 16 16
Manufacturing, Packaging or Shipping Problem 16 16
Contamination /Decontamination Problem 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Break 14 14
Appropriate Term/Code Not Available 13 13
Device Packaging Compromised 12 12
Contamination 12 12
Unraveled Material 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Nonstandard Device 8 8
Delivered as Unsterile Product 7 8
Product Quality Problem 7 7
Entrapment of Device 7 7
Flaked 7 7
Material Split, Cut or Torn 7 7
Physical Resistance/Sticking 7 7
Defective Component 5 5
Defective Device 4 4
Fluid/Blood Leak 4 4
Device Contaminated During Manufacture or Shipping 4 4
Disassembly 3 3
Material Discolored 3 3
Explanted 2 2
False Negative Result 2 2
Device Slipped 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Melted 2 2
Device Dislodged or Dislocated 2 2
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Therapeutic or Diagnostic Output Failure 2 2
Torn Material 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
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
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
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 297 355
No Consequences Or Impact To Patient 266 267
No Known Impact Or Consequence To Patient 239 240
No Patient Involvement 143 143
No Information 114 114
Insufficient Information 54 54
Foreign Body In Patient 37 37
Device Embedded In Tissue or Plaque 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unintended Radiation Exposure 4 4
Not Applicable 2 2
Injury 2 2
Skin Tears 2 2
Hemorrhage/Bleeding 2 2
Skin Irritation 2 2
Tissue Damage 1 1
Urinary Retention 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Death 1 1
Hyperbilirubinemia 1 1
Unspecified Infection 1 1
Inflammation 1 1
Burn, Thermal 1 1
Blood Loss 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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