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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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New Search show TPLC since Back to Search Results
Device drape, surgical
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
2019 41 41
2020 16 16
2021 41 41
2022 19 19
2023 32 32
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Material Puncture/Hole 25 25
Material Split, Cut or Torn 13 13
Human-Device Interface Problem 11 11
Contamination /Decontamination Problem 9 9
Break 6 6
Detachment of Device or Device Component 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Contamination 5 5
Patient Device Interaction Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Device Damaged Prior to Use 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Packaging Problem 2 2
Fluid/Blood Leak 2 2
Output Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Leak/Splash 1 1
Incomplete or Inadequate Connection 1 1
Component Incompatible 1 1
Unsealed Device Packaging 1 1
Material Separation 1 1
Material Fragmentation 1 1
Display or Visual Feedback Problem 1 1
Blocked Connection 1 1
Nonstandard Device 1 1
Defective Device 1 1
Material Perforation 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Material Integrity Problem 1 1
Material Discolored 1 1
Material Disintegration 1 1
No Apparent Adverse Event 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Component Missing 1 1
No Flow 1 1
Delivered as Unsterile Product 1 1
Component Misassembled 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 40 40
Skin Tears 31 31
Pain 19 19
Erythema 16 16
Blister 13 13
Insufficient Information 11 11
Skin Inflammation/ Irritation 9 9
Skin Burning Sensation 8 8
Swelling/ Edema 7 7
Burning Sensation 7 7
Injury 4 4
Foreign Body In Patient 3 3
No Consequences Or Impact To Patient 3 3
Burn(s) 3 3
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
Exposure to Body Fluids 2 2
Vessel Or Plaque, Device Embedded In 1 1
Hypersensitivity/Allergic reaction 1 1
Local Reaction 1 1
Scarring 1 1
Increased Sensitivity 1 1
Skin Irritation 1 1
Swelling 1 1
Discomfort 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Missing Value Reason 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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