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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
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2016
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2019
2020
2021
2022
2023
2024
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Device
suture, absorbable
Product Code
GAK
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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
54
54
Break
50
50
Material Separation
13
13
Material Frayed
4
4
Material Integrity Problem
3
3
Appropriate Term/Code Not Available
3
3
Insufficient Information
1
1
Patient-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28
28
Unspecified Infection
23
23
No Consequences Or Impact To Patient
23
23
Insufficient Information
15
15
Pain
14
14
Wound Dehiscence
13
13
Hemorrhage/Bleeding
9
9
Not Applicable
8
8
Post Operative Wound Infection
7
7
Impaired Healing
7
7
Inflammation
6
6
Erythema
6
6
No Code Available
6
6
Swelling/ Edema
5
5
Hematoma
5
5
Abscess
5
5
Pocket Erosion
5
5
Scar Tissue
3
3
Urinary Retention
3
3
Failure to Anastomose
3
3
Fever
3
3
Foreign Body In Patient
3
3
Blood Loss
2
2
Abdominal Distention
2
2
Fluid Discharge
2
2
Hypersensitivity/Allergic reaction
2
2
Death
2
2
Purulent Discharge
2
2
Perforation
2
2
Urinary Tract Infection
1
1
Obstruction/Occlusion
1
1
Hernia
1
1
Deformity/ Disfigurement
1
1
Sepsis
1
1
Seroma
1
1
Swelling
1
1
Itching Sensation
1
1
Necrosis
1
1
Abrasion
1
1
Anaphylactic Shock
1
1
Bacterial Infection
1
1
Cellulitis
1
1
Incontinence
1
1
Fistula
1
1
Eye Injury
1
1
Skin Inflammation/ Irritation
1
1
Unspecified Tissue Injury
1
1
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