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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

MDR Year MDR Reports MDR Events
2021 41 41
2022 19 19
2023 32 32
2024 19 19
2025 24 24
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Material Split, Cut or Torn 11 11
Material Puncture/Hole 11 11
Human-Device Interface Problem 11 11
Manufacturing, Packaging or Shipping Problem 6 6
Break 5 5
Contamination 5 5
Contamination /Decontamination Problem 5 5
Patient Device Interaction Problem 4 4
Appropriate Term/Code Not Available 4 4
Detachment of Device or Device Component 4 4
Improper or Incorrect Procedure or Method 3 3
Device Damaged Prior to Use 3 3
Insufficient Information 3 3
Device Contamination with Chemical or Other Material 3 3
Output Problem 2 2
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 2 2
Use of Device Problem 2 2
Fluid/Blood Leak 1 1
Display or Visual Feedback Problem 1 1
Component Incompatible 1 1
Nonstandard Device 1 1
Component Misassembled 1 1
Contamination of Device Ingredient or Reagent 1 1
Residue After Decontamination 1 1
Material Separation 1 1
Product Quality Problem 1 1
Packaging Problem 1 1
Material Deformation 1 1
Blocked Connection 1 1
Component Missing 1 1
Device Difficult to Setup or Prepare 1 1
Material Discolored 1 1
Adhesive Too Strong 1 1
Difficult to Insert 1 1
Degraded 1 1
Unsealed Device Packaging 1 1
Material Disintegration 1 1
Incomplete or Inadequate Connection 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 66 66
Skin Tears 31 31
Insufficient Information 14 14
Pain 14 14
Erythema 12 12
Blister 11 11
Skin Inflammation/ Irritation 7 7
Burning Sensation 7 7
Swelling/ Edema 7 7
Skin Burning Sensation 5 5
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
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Laceration(s) 2 2
Full thickness (Third Degree) Burn 2 2
Failure of Implant 1 1
Local Reaction 1 1
Contact Dermatitis 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1
Bacterial Infection 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
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 Medline Industries, LP II Feb-17-2026
8 O&M HALYARD INC II Sep-04-2025
9 O&M HALYARD, INC. II Jan-17-2025
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