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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 32 32
2019 41 41
2020 16 16
2021 41 41
2022 19 19
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 29 29
Material Puncture/Hole 27 27
Material Split, Cut or Torn 14 14
Contamination /Decontamination Problem 11 11
Break 7 7
Hole In Material 7 7
Device Contamination with Chemical or Other Material 6 6
Detachment of Device or Device Component 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Patient Device Interaction Problem 4 4
Contamination 4 4
Output Problem 3 3
Packaging Problem 3 3
Insufficient Information 3 3
Material Integrity Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Connection Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Perforation 2 2
Material Disintegration 2 2
Difficult to Insert 2 2
Product Quality Problem 2 2
Fluid/Blood Leak 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Material Separation 1 1
Use of Device Problem 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Material Discolored 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Device Markings/Labelling Problem 1 1
Human-Device Interface Problem 1 1
Incomplete or Inadequate Connection 1 1
No Flow 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 59 59
No Clinical Signs, Symptoms or Conditions 33 33
Skin Tears 20 20
Pain 12 12
Blister 12 12
Skin Inflammation/ Irritation 9 9
Insufficient Information 9 9
Erythema 9 9
Skin Burning Sensation 8 8
No Information 5 5
Injury 4 4
Burn(s) 4 4
Ulceration 4 4
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 3 3
Discomfort 2 2
Reaction 2 2
No Patient Involvement 2 2
Hemorrhage/Bleeding 2 2
Rash 2 2
Local Reaction 1 1
Scarring 1 1
Increased Sensitivity 1 1
Skin Irritation 1 1
Swelling 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Vessel Or Plaque, Device Embedded In 1 1
No Code Available 1 1
Missing Value Reason 1 1
Device Embedded In Tissue or Plaque 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 Arrow International Inc II May-30-2018
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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