Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
bandage, cast
Product Code
ITG
Regulation Number
890.3025
Device Class
1
MDR Year
MDR Reports
MDR Events
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
3
3
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
6
6
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Collapse
2
2
Device Operates Differently Than Expected
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Unsealed Device Packaging
1
1
Failure to Obtain Sample
1
1
Defective Component
1
1
Device Contamination with Chemical or Other Material
1
1
Self-Activation or Keying
1
1
Temperature Problem
1
1
Device Slipped
1
1
Break
1
1
Mechanical Problem
1
1
Crack
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
12
12
No Clinical Signs, Symptoms or Conditions
8
8
Partial thickness (Second Degree) Burn
4
4
No Consequences Or Impact To Patient
4
4
No Known Impact Or Consequence To Patient
3
3
Unspecified Infection
2
2
Skin Infection
2
2
No Information
2
2
Skin Inflammation/ Irritation
2
2
Blister
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Abrasion
1
1
Skin Disorders
1
1
Rash
1
1
Discomfort
1
1
Swelling
1
1
Insufficient Information
1
1
Pain
1
1
Congenital Defect/Deformity
1
1
Fluid Discharge
1
1
Muscle/Tendon Damage
1
1
Skin Tears
1
1
Pressure Sores
1
1
Full thickness (Third Degree) Burn
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Apr-24-2018
-
-