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TPLC
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Device
drape, surgical
Regulation Description
Surgical drape and drape accessories.
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
2020
16
16
2021
41
41
2022
19
19
2023
32
32
2024
19
19
2025
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
21
21
Material Split, Cut or Torn
13
13
Material Puncture/Hole
11
11
Human-Device Interface Problem
11
11
Contamination /Decontamination Problem
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Break
5
5
Patient Device Interaction Problem
4
4
Detachment of Device or Device Component
4
4
Appropriate Term/Code Not Available
4
4
Device Damaged Prior to Use
3
3
Insufficient Information
3
3
Contamination
3
3
Improper or Incorrect Procedure or Method
3
3
Output Problem
2
2
Use of Device Problem
2
2
Packaging Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Fluid/Blood Leak
2
2
Device Contaminated During Manufacture or Shipping
1
1
Entrapment of Device
1
1
Incomplete or Inadequate Connection
1
1
Material Disintegration
1
1
Unsealed Device Packaging
1
1
Material Fragmentation
1
1
Difficult to Insert
1
1
Material Discolored
1
1
Device Difficult to Setup or Prepare
1
1
Component Missing
1
1
Blocked Connection
1
1
Product Quality Problem
1
1
Material Separation
1
1
Tear, Rip or Hole in Device Packaging
1
1
No Apparent Adverse Event
1
1
Component Misassembled
1
1
Nonstandard Device
1
1
Component Incompatible
1
1
Display or Visual Feedback Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
64
64
Skin Tears
32
32
Pain
16
16
Erythema
15
15
Blister
13
13
Insufficient Information
13
13
Skin Inflammation/ Irritation
9
9
Skin Burning Sensation
8
8
No Known Impact Or Consequence To Patient
7
7
Burning Sensation
7
7
Swelling/ Edema
7
7
Foreign Body In Patient
4
4
Burn(s)
3
3
Exposure to Body Fluids
3
3
Unspecified Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Wound Dehiscence
2
2
Laceration(s)
2
2
Hemorrhage/Bleeding
2
2
No Consequences Or Impact To Patient
2
2
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Local Reaction
1
1
Swelling
1
1
Discomfort
1
1
Missing Value Reason
1
1
Bacterial Infection
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-17-2025
3
MEDLINE INDUSTRIES, LP - Northfield
II
Oct-23-2024
4
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
5
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
6
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
7
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
8
O&M HALYARD, INC.
II
Jan-17-2025
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