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TPLC
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show TPLC since
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2024
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Device
bandage, cast
Product Code
ITG
Regulation Number
890.3025
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
1
1
2017
4
4
2018
15
15
2019
4
4
2020
3
3
2021
5
5
2022
9
9
2023
3
3
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
10
10
Material Too Soft/Flexible
9
9
Adverse Event Without Identified Device or Use Problem
5
5
Insufficient Information
4
4
Appropriate Term/Code Not Available
3
3
Device Operates Differently Than Expected
2
2
Collapse
2
2
Crack
1
1
Mechanical Problem
1
1
Unsealed Device Packaging
1
1
Self-Activation or Keying
1
1
Device Slipped
1
1
Defective Component
1
1
Failure to Obtain Sample
1
1
Patient-Device Incompatibility
1
1
Environmental Particulates
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Temperature Problem
1
1
Break
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
12
12
No Clinical Signs, Symptoms or Conditions
7
7
Partial thickness (Second Degree) Burn
4
4
No Consequences Or Impact To Patient
4
4
Rash
3
3
No Known Impact Or Consequence To Patient
3
3
Skin Infection
2
2
Skin Inflammation/ Irritation
2
2
Unspecified Infection
2
2
No Information
2
2
Blister
2
2
Skin Disorders
1
1
No Code Available
1
1
Full thickness (Third Degree) Burn
1
1
Skin Tears
1
1
Fluid Discharge
1
1
Pain
1
1
Abrasion
1
1
Bruise/Contusion
1
1
Congenital Defect/Deformity
1
1
Swelling
1
1
Pressure Sores
1
1
Discomfort
1
1
Insufficient Information
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Sep-18-2013
2
Integra LifeSciences Corp.
II
Apr-24-2018
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