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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
2
2
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
12
12
Human-Device Interface Problem
11
11
Material Puncture/Hole
9
9
Contamination /Decontamination Problem
7
7
Break
5
5
Patient Device Interaction Problem
4
4
Detachment of Device or Device Component
4
4
Appropriate Term/Code Not Available
4
4
Contamination
3
3
Device Damaged Prior to Use
3
3
Improper or Incorrect Procedure or Method
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Device Contamination with Chemical or Other Material
2
2
Output Problem
2
2
Fluid/Blood Leak
2
2
Insufficient Information
2
2
Packaging Problem
2
2
Use of Device Problem
2
2
Material Disintegration
1
1
Component Misassembled
1
1
Incomplete or Inadequate Connection
1
1
Component Missing
1
1
Component Incompatible
1
1
Entrapment of Device
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Difficult to Setup or Prepare
1
1
Unsealed Device Packaging
1
1
Difficult to Insert
1
1
Tear, Rip or Hole in Device Packaging
1
1
No Apparent Adverse Event
1
1
Material Separation
1
1
Nonstandard Device
1
1
Product Quality Problem
1
1
Display or Visual Feedback Problem
1
1
Material Fragmentation
1
1
Blocked Connection
1
1
Material Discolored
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
55
55
Skin Tears
31
31
Pain
16
16
Erythema
15
15
Blister
13
13
Insufficient Information
11
11
Skin Inflammation/ Irritation
9
9
Skin Burning Sensation
8
8
Burning Sensation
7
7
Swelling/ Edema
7
7
No Known Impact Or Consequence To Patient
7
7
Foreign Body In Patient
4
4
Exposure to Body Fluids
3
3
Burn(s)
3
3
No Consequences Or Impact To Patient
2
2
Hemorrhage/Bleeding
2
2
Laceration(s)
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Wound Dehiscence
2
2
Unspecified Infection
2
2
Bacterial Infection
1
1
Failure of Implant
1
1
Hypersensitivity/Allergic reaction
1
1
Device Embedded In Tissue or Plaque
1
1
Missing Value Reason
1
1
Discomfort
1
1
Swelling
1
1
Local Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
MEDLINE INDUSTRIES, LP - Northfield
II
Oct-23-2024
3
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
4
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
5
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
6
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
7
O&M HALYARD, INC.
II
Jan-17-2025
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