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
3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
A PLUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED VASCULAR DYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON BELGIE BVBA
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSIPITAL DISPOSABLES
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU HOLYMED PRODUCTS CO LTD
  SUBSTANTIALLY EQUIVALENT 1
COBES INDUSTRIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 1
COVALON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXACT MEDICAL MANUFACTURING, INC
  SUBSTANTIALLY EQUIVALENT 4
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRIFFITH-LUCAS LLC
  SUBSTANTIALLY EQUIVALENT 1
HINSON AND HALE MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDSURG CONNECTION
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADSCAN MEDICAL EQUIPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGIVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WHITNEY MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 26 26
2015 32 32
2016 56 56
2017 30 30
2018 32 32
2019 41 41
2020 16 16
2021 41 41
2022 19 19
2023 32 32
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35 35
Hole In Material 31 31
Material Puncture/Hole 28 28
Leak/Splash 22 22
Device Contamination with Chemical or Other Material 20 20
Device Contamination with Body Fluid 18 18
Appropriate Term/Code Not Available 15 15
Material Split, Cut or Torn 14 14
Contamination /Decontamination Problem 13 13
Break 13 13
Human-Device Interface Problem 11 11
Insufficient Information 10 10
Torn Material 8 8
Contamination 8 8
Fluid/Blood Leak 8 8
No Apparent Adverse Event 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Operates Differently Than Expected 6 6
Detachment of Device or Device Component 5 5
Failure To Adhere Or Bond 5 5
Detachment Of Device Component 4 4
Delivered as Unsterile Product 4 4
Improper or Incorrect Procedure or Method 4 4
Device Damaged Prior to Use 4 4
Defective Device 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Integrity Problem 4 4
Patient Device Interaction Problem 4 4
Output Problem 3 3
Packaging Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Patient-Device Incompatibility 3 3
Unsealed Device Packaging 3 3
Nonstandard Device 3 3
Product Quality Problem 2 2
Material Rupture 2 2
Peeled/Delaminated 2 2
Component Falling 2 2
Loss of or Failure to Bond 2 2
Difficult to Insert 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Connection Problem 2 2
Device Packaging Compromised 2 2
Material Perforation 2 2
Out-Of-Box Failure 2 2
Chemical Spillage 2 2
Protective Measures Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
No Flow 1 1
Material Deformation 1 1
Device Issue 1 1
Structural Problem 1 1
Split 1 1
Device Displays Incorrect Message 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Blocked Connection 1 1
Flaked 1 1
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
High impedance 1 1
Thermal Decomposition of Device 1 1
Component Incompatible 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Component Missing 1 1
Fitting Problem 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Unknown (for use when the device problem is not known) 1 1
Material Separation 1 1
Sticking 1 1
Use of Device Problem 1 1
Material Opacification 1 1
Overheating of Device 1 1
Component Misassembled 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 123 123
No Clinical Signs, Symptoms or Conditions 44 44
Skin Tears 36 36
Pain 19 19
No Information 18 18
Erythema 17 17
No Code Available 16 16
Blister 13 13
Insufficient Information 11 11
No Consequences Or Impact To Patient 11 11
Skin Inflammation/ Irritation 9 9
Skin Burning Sensation 8 8
Swelling/ Edema 7 7
Burning Sensation 7 7
No Patient Involvement 6 6
Rash 6 6
Burn(s) 5 5
Injury 5 5
Reaction 5 5
Foreign Body In Patient 4 4
Ulceration 4 4
Skin Irritation 3 3
Swelling 3 3
Local Reaction 3 3
Unspecified Infection 3 3
Exposure to Body Fluids 3 3
Hemorrhage/Bleeding 3 3
Blood Loss 3 3
Discomfort 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Fall 2 2
Death 2 2
Irritation 2 2
Laceration(s) 2 2
Sepsis 2 2
Itching Sensation 1 1
Scar Tissue 1 1
Scarring 1 1
Increased Sensitivity 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Unknown (for use when the patient's condition is not known) 1 1
Halo 1 1
Urinary Frequency 1 1
Dry Eye(s) 1 1
Dyspnea 1 1
Fever 1 1
Hypothermia 1 1
Hypoxia 1 1
Bruise/Contusion 1 1
Breast Cancer 1 1
Failure to Anastomose 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Abrasion 1 1
Bacterial Infection 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Breast Mass 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Missing Value Reason 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 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 Blue Belt Technologies MN II Aug-21-2013
4 Cardinal Health 200, LLC II Jul-07-2017
5 Custom Medical Specialties, Inc. II Feb-12-2014
6 Customed, Inc II Apr-14-2016
7 Customed, Inc II Sep-03-2015
8 Customed, Inc I Dec-16-2014
9 Customed, Inc I Aug-29-2014
10 Ecolab Inc III Dec-14-2016
11 Ecolab Inc II Sep-07-2016
12 Ecolab Inc II Feb-10-2014
13 Halyard Health, Inc II Dec-08-2016
14 Intuitive Surgical, Inc. II Apr-06-2015
15 Kimberly-Clark Corporation II Nov-07-2012
16 Kimberly-Clark Corporation III Sep-20-2012
17 Kimberly-Clark Corporation II Jul-21-2011
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
21 Microtek Medical, Inc. II Dec-10-2010
22 Volcano Corporation II Mar-03-2016
-
-