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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 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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