TPLC - Total Product Life Cycle

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Device	gauze/sponge, internal, x-ray detectable
Regulation Description	Nonabsorbable gauze for internal use.
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	188	188
Material Fragmentation	156	158
Material Frayed	128	204
Component Missing	44	44
Material Separation	33	33
Manufacturing, Packaging or Shipping Problem	19	19
Material Disintegration	18	18
Material Integrity Problem	13	13
Delivered as Unsterile Product	11	15
Device Misassembled During Manufacturing /Shipping	11	11
Contamination	10	10
Incorrect Measurement	9	9
Contamination /Decontamination Problem	9	9
Break	7	7
Entrapment of Device	7	7
Defective Device	7	7
Device Contaminated During Manufacture or Shipping	5	5
Material Split, Cut or Torn	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Nonstandard Device	4	4
Product Quality Problem	4	4
False Negative Result	4	4
Physical Resistance/Sticking	4	4
Unraveled Material	4	4
Device Contamination with Chemical or Other Material	3	3
Packaging Problem	3	3
Particulates	3	3
Insufficient Information	3	3
Defective Component	2	2
Device Damaged Prior to Use	2	2
Separation Problem	2	2
Device Slipped	2	4
No Apparent Adverse Event	2	2
Component Misassembled	2	2
Illegible Information	2	2
Appropriate Term/Code Not Available	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Patient Device Interaction Problem	1	1
Radiation Output Failure	1	1
Difficult to Insert	1	1
Unable to Obtain Readings	1	1
Foreign material	1	1
Fail-Safe Problem	1	1
Material Discolored	1	1
Separation Failure	1	1
Explanted	1	1
Misassembled	1	1
Output Problem	1	1
Incomplete or Missing Packaging	1	1
Fire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	567	645
Insufficient Information	84	86
Foreign Body In Patient	48	48
Unintended Radiation Exposure	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Bleeding	4	4
Tissue Breakdown	3	3
Unspecified Infection	2	2
Inflammation	1	1
No Known Impact Or Consequence To Patient	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	Carefree Surgical Specialties	II	Aug-08-2025
3	Covidien	II	Mar-21-2024
4	Cypress Medical Products LLC	II	Sep-14-2021