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TPLC
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show TPLC since
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2023
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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
CONTROLRAD, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
32
32
2019
41
41
2020
16
16
2021
41
41
2022
19
19
2023
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
29
29
Material Puncture/Hole
27
27
Material Split, Cut or Torn
14
14
Contamination /Decontamination Problem
11
11
Break
7
7
Hole In Material
7
7
Device Contamination with Chemical or Other Material
6
6
Detachment of Device or Device Component
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Patient Device Interaction Problem
4
4
Contamination
4
4
Output Problem
3
3
Packaging Problem
3
3
Insufficient Information
3
3
Material Integrity Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Connection Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Material Perforation
2
2
Material Disintegration
2
2
Difficult to Insert
2
2
Product Quality Problem
2
2
Fluid/Blood Leak
2
2
Improper or Incorrect Procedure or Method
2
2
Fitting Problem
1
1
Material Fragmentation
1
1
Material Rupture
1
1
Material Separation
1
1
Use of Device Problem
1
1
Leak/Splash
1
1
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
Display or Visual Feedback Problem
1
1
Entrapment of Device
1
1
Material Discolored
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Device Markings/Labelling Problem
1
1
Human-Device Interface Problem
1
1
Incomplete or Inadequate Connection
1
1
No Flow
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
59
59
No Clinical Signs, Symptoms or Conditions
33
33
Skin Tears
20
20
Pain
12
12
Blister
12
12
Skin Inflammation/ Irritation
9
9
Insufficient Information
9
9
Erythema
9
9
Skin Burning Sensation
8
8
No Information
5
5
Injury
4
4
Burn(s)
4
4
Ulceration
4
4
No Consequences Or Impact To Patient
3
3
Foreign Body In Patient
3
3
Discomfort
2
2
Reaction
2
2
No Patient Involvement
2
2
Hemorrhage/Bleeding
2
2
Rash
2
2
Local Reaction
1
1
Scarring
1
1
Increased Sensitivity
1
1
Skin Irritation
1
1
Swelling
1
1
Hypersensitivity/Allergic reaction
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Vessel Or Plaque, Device Embedded In
1
1
No Code Available
1
1
Missing Value Reason
1
1
Device Embedded In Tissue or Plaque
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
Arrow International Inc
II
May-30-2018
3
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
4
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
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