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
Material Fragmentation	222	222
Detachment of Device or Device Component	205	205
Material Frayed	165	236
Component Missing	66	66
Material Separation	43	43
Device Misassembled During Manufacturing /Shipping	17	17
Material Disintegration	15	15
Material Integrity Problem	14	14
Contamination /Decontamination Problem	14	14
Packaging Problem	13	13
Contamination	13	13
Delivered as Unsterile Product	10	13
Manufacturing, Packaging or Shipping Problem	10	10
Break	9	9
Incorrect Measurement	9	9
Nonstandard Device	8	8
Unraveled Material	8	8
Material Split, Cut or Torn	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Product Quality Problem	6	6
Defective Device	6	6
Device Contaminated During Manufacture or Shipping	5	5
Device Contamination with Chemical or Other Material	5	5
Entrapment of Device	5	5
Incomplete or Missing Packaging	5	5
Physical Resistance/Sticking	5	5
Particulates	5	5
Fluid/Blood Leak	4	4
Component Misassembled	3	3
Patient Device Interaction Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Component	2	2
Material Discolored	2	2
Separation Problem	2	2
No Apparent Adverse Event	2	2
Illegible Information	2	2
Appropriate Term/Code Not Available	2	2
Melted	2	2
Device Slipped	2	2
Radiation Output Failure	1	1
Unable to Obtain Readings	1	1
Foreign material	1	1
Insufficient Information	1	1
Separation Failure	1	1
Device Markings/Labelling Problem	1	1
Misassembled	1	1
Explanted	1	1
Output Problem	1	1
Fire	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	487	559
No Consequences Or Impact To Patient	128	129
Insufficient Information	82	82
No Known Impact Or Consequence To Patient	57	58
No Patient Involvement	55	55
Foreign Body In Patient	47	47
No Information	22	22
Device Embedded In Tissue or Plaque	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Unintended Radiation Exposure	5	5
Hemorrhage/Bleeding	4	4
Unspecified Infection	1	1
No Code Available	1	1
Inflammation	1	1
Burn, Thermal	1	1
Blood Loss	1	1
Injury	1	1
Urinary Retention	1	1
Tissue Damage	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
5	Medical Action Industries Inc	II	Mar-28-2019