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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable
Product CodeGAK
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2019 24 24
2020 22 22
2021 13 13
2022 20 20
2023 33 33
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 68 68
Break 52 52
Material Separation 16 16
Material Frayed 4 4
Material Integrity Problem 4 4
Appropriate Term/Code Not Available 3 3
Improper Chemical Reaction 3 3
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Unspecified Infection 27 27
No Consequences Or Impact To Patient 23 23
Insufficient Information 21 21
Pain 18 18
Wound Dehiscence 14 14
Erythema 10 10
Hemorrhage/Bleeding 9 9
Not Applicable 8 8
Impaired Healing 7 7
Inflammation 7 7
Post Operative Wound Infection 7 7
Pocket Erosion 6 6
No Code Available 6 6
Swelling/ Edema 6 6
Abscess 5 5
Hematoma 5 5
Hypersensitivity/Allergic reaction 4 4
Urinary Retention 4 4
Foreign Body In Patient 4 4
Failure to Anastomose 3 3
Scar Tissue 3 3
Fever 3 3
Itching Sensation 2 2
Purulent Discharge 2 2
Blood Loss 2 2
Perforation 2 2
Abdominal Distention 2 2
Fluid Discharge 2 2
Skin Inflammation/ Irritation 2 2
Death 2 2
Incontinence 1 1
Foreign Body Reaction 1 1
Skin Discoloration 1 1
Cellulitis 1 1
Seroma 1 1
Abrasion 1 1
Swelling 1 1
Obstruction/Occlusion 1 1
Hernia 1 1
Nerve Damage 1 1
Necrosis 1 1
Eye Injury 1 1
Pneumonia 1 1
Unspecified Tissue Injury 1 1
Anaphylactic Shock 1 1
Sepsis 1 1
Deformity/ Disfigurement 1 1
Bacterial Infection 1 1
Neuropathy 1 1

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