Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 57 60

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 215 215
Detachment of Device or Device Component 190 190
Material Frayed 154 216
Component Missing 65 65
Material Separation 39 39
Device Misassembled During Manufacturing /Shipping 17 17
Material Integrity Problem 14 14
Contamination /Decontamination Problem 14 14
Material Disintegration 14 14
Contamination 13 13
Packaging Problem 13 13
Manufacturing, Packaging or Shipping Problem 10 10
Break 9 9
Incorrect Measurement 9 9
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
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Separation Problem 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
Illegible Information 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Protective Measures Problem 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 443 504
No Consequences Or Impact To Patient 128 129
Insufficient Information 79 79
No Known Impact Or Consequence To Patient 57 58
No Patient Involvement 55 55
Foreign Body In Patient 40 40
No Information 22 22
Device Embedded In Tissue or Plaque 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unintended Radiation Exposure 5 5
Hemorrhage/Bleeding 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
-
-