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TPLC
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show TPLC since
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2024
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Device
drape, surgical
Product Code
KKX
Regulation Number
878.4370
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M COMPANY
SUBSTANTIALLY EQUIVALENT
1
AVERY DENNISON BELGIE BVBA
SUBSTANTIALLY EQUIVALENT
1
AVERY DENNISON MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
CONTROLRAD, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
41
41
2020
16
16
2021
41
41
2022
19
19
2023
32
32
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Puncture/Hole
25
25
Adverse Event Without Identified Device or Use Problem
25
25
Material Split, Cut or Torn
13
13
Human-Device Interface Problem
11
11
Contamination /Decontamination Problem
9
9
Break
6
6
Detachment of Device or Device Component
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Contamination
5
5
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
4
4
Insufficient Information
3
3
Device Contamination with Chemical or Other Material
3
3
Device Damaged Prior to Use
3
3
Tear, Rip or Hole in Device Packaging
2
2
Improper or Incorrect Procedure or Method
2
2
Device Contaminated During Manufacture or Shipping
2
2
Product Quality Problem
2
2
Fluid/Blood Leak
2
2
Output Problem
2
2
Packaging Problem
2
2
No Apparent Adverse Event
1
1
Component Misassembled
1
1
Incomplete or Inadequate Connection
1
1
Material Fragmentation
1
1
Difficult to Insert
1
1
Leak/Splash
1
1
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Device Difficult to Setup or Prepare
1
1
Material Separation
1
1
Use of Device Problem
1
1
Material Discolored
1
1
Material Disintegration
1
1
Display or Visual Feedback Problem
1
1
Entrapment of Device
1
1
Material Integrity Problem
1
1
No Flow
1
1
Connection Problem
1
1
Material Perforation
1
1
Component Incompatible
1
1
Defective Device
1
1
Blocked Connection
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
42
42
No Known Impact Or Consequence To Patient
40
40
Skin Tears
31
31
Pain
19
19
Erythema
16
16
Blister
13
13
Insufficient Information
11
11
Skin Inflammation/ Irritation
9
9
Skin Burning Sensation
8
8
Swelling/ Edema
7
7
Burning Sensation
7
7
Injury
4
4
Foreign Body In Patient
3
3
No Consequences Or Impact To Patient
3
3
Exposure to Body Fluids
3
3
Burn(s)
3
3
Hemorrhage/Bleeding
2
2
Laceration(s)
2
2
Vessel Or Plaque, Device Embedded In
1
1
Discomfort
1
1
No Patient Involvement
1
1
Hypersensitivity/Allergic reaction
1
1
Local Reaction
1
1
Scarring
1
1
Increased Sensitivity
1
1
Skin Irritation
1
1
Swelling
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Missing Value Reason
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
3
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
4
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
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