TPLC - Total Product Life Cycle

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Device	gauze/sponge, internal, x-ray detectable
Product Code	GDY
Regulation Number	878.4450
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	177	177
Material Fragmentation	167	167
Material Frayed	135	204
Component Missing	41	41
Material Separation	35	35
Device Misassembled During Manufacturing /Shipping	13	13
Material Disintegration	13	13
Material Integrity Problem	12	12
Contamination /Decontamination Problem	11	11
Contamination	11	11
Manufacturing, Packaging or Shipping Problem	11	11
Packaging Problem	10	10
Incorrect Measurement	9	9
Delivered as Unsterile Product	9	12
Break	7	7
Nonstandard Device	5	5
Material Split, Cut or Torn	5	5
Entrapment of Device	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Unraveled Material	5	5
Defective Device	5	5
Device Contamination with Chemical or Other Material	4	4
Product Quality Problem	4	4
Physical Resistance/Sticking	4	4
Particulates	3	3
Device Contaminated During Manufacture or Shipping	3	3
Component Misassembled	3	3
Defective Component	2	2
Therapeutic or Diagnostic Output Failure	2	2
Incomplete or Missing Packaging	2	2
Separation Problem	2	2
Device Slipped	2	2
No Apparent Adverse Event	2	2
Illegible Information	2	2
Appropriate Term/Code Not Available	2	2
Foreign material	1	1
Insufficient Information	1	1
Separation Failure	1	1
Patient Device Interaction Problem	1	1
Radiation Output Failure	1	1
Device Markings/Labelling Problem	1	1
Unable to Obtain Readings	1	1
Explanted	1	1
Material Discolored	1	1
Output Problem	1	1
Misassembled	1	1
Fire	1	1
False Negative Result	1	1
No Display/Image	1	1
Radiation Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	492	564
Insufficient Information	82	82
No Consequences Or Impact To Patient	46	46
Foreign Body In Patient	45	45
No Patient Involvement	19	19
No Known Impact Or Consequence To Patient	18	18
Device Embedded In Tissue or Plaque	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Unintended Radiation Exposure	5	5
No Information	4	4
Hemorrhage/Bleeding	4	4
Unspecified Infection	1	1
Inflammation	1	1
Urinary Retention	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	Covidien	II	Mar-21-2024
4	Cypress Medical Products LLC	II	Sep-14-2021