Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 3 3

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
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
Exposure to Body Fluids 3 3
Burn(s) 3 3
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Vessel Or Plaque, Device Embedded In 1 1
Discomfort 1 1
No Patient Involvement 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
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
-
-