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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical
Regulation Description Surgical drape and drape accessories.
Product CodeKKX
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22 22
Material Split, Cut or Torn 14 14
Human-Device Interface Problem 11 11
Material Puncture/Hole 11 11
Contamination /Decontamination Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Break 5 5
Contamination 5 5
Appropriate Term/Code Not Available 4 4
Detachment of Device or Device Component 4 4
Patient Device Interaction Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Device Contamination with Chemical or Other Material 3 3
Device Damaged Prior to Use 3 3
Insufficient Information 3 3
Fluid/Blood Leak 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Physical Resistance/Sticking 2 2
Output Problem 2 2
Material Fragmentation 1 1
Difficult to Insert 1 1
Adhesive Too Strong 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Degraded 1 1
Component Missing 1 1
Blocked Connection 1 1
Unsealed Device Packaging 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Disintegration 1 1
Incomplete or Inadequate Connection 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
Entrapment of Device 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Skin Tears 34 34
Pain 17 17
Erythema 15 15
Insufficient Information 14 14
Blister 13 13
Skin Inflammation/ Irritation 10 10
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
Hypersensitivity/Allergic reaction 2 2
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
No Consequences Or Impact To Patient 2 2
Full thickness (Third Degree) Burn 2 2
Failure of Implant 1 1
Local Reaction 1 1
Swelling 1 1
Discomfort 1 1
Missing Value Reason 1 1
Contact Dermatitis 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 Sep-04-2025
9 O&M HALYARD, INC. II Jan-17-2025
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