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TPLC
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Device
suture, nonabsorbable, steel, monofilament and multifilament, sterile
Product Code
GAQ
Regulation Number
878.4495
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONEXTIONS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
FOOSIN MEDICAL SUPPLIES INC., LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K193209
Wego-Stainless Steel
MDR Year
MDR Reports
MDR Events
2019
76
76
2020
52
52
2021
39
39
2022
70
70
2023
100
100
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
152
152
Break
145
145
Detachment of Device or Device Component
50
50
Adverse Event Without Identified Device or Use Problem
17
17
Material Twisted/Bent
12
12
Defective Component
6
6
Dull, Blunt
6
6
Unraveled Material
4
4
Delivered as Unsterile Product
4
4
Product Quality Problem
4
4
Use of Device Problem
2
2
Material Frayed
2
2
Device Contaminated During Manufacture or Shipping
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Unclear Information
2
2
Appropriate Term/Code Not Available
2
2
Noise, Audible
1
1
Migration
1
1
Packaging Problem
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Misfire
1
1
Component Missing
1
1
Loose or Intermittent Connection
1
1
Corroded
1
1
Disconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
212
212
No Consequences Or Impact To Patient
81
81
Insufficient Information
18
18
Not Applicable
17
17
Hemorrhage/Bleeding
11
11
Foreign Body In Patient
9
9
No Known Impact Or Consequence To Patient
8
8
No Code Available
8
8
Wound Dehiscence
8
8
Unspecified Infection
7
7
Pain
6
6
Bone Fracture(s)
4
4
Tissue Damage
4
4
Tissue Breakdown
3
3
Toxicity
3
3
Hemostasis
3
3
Hypersensitivity/Allergic reaction
3
3
Local Reaction
3
3
Inflammation
3
3
Foreign Body Reaction
3
3
Itching Sensation
2
2
Granuloma
2
2
Blood Loss
2
2
Unspecified Tissue Injury
2
2
Unintended Radiation Exposure
2
2
No Information
2
2
Radiation Exposure, Unintended
1
1
Swelling/ Edema
1
1
Renal Impairment
1
1
Muscle/Tendon Damage
1
1
No Patient Involvement
1
1
Respiratory Failure
1
1
Rupture
1
1
Dyspnea
1
1
Erythema
1
1
Fever
1
1
Ischemia
1
1
Sepsis
1
1
Skin Irritation
1
1
Pneumonia
1
1
Rash
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ethicon, Inc.
II
Jun-19-2019
2
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
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