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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device negative pressure wound therapy powered suction pump
Regulation Description Powered suction pump.
Definition For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product CodeOMP
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
4L HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED TISSUE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 2
BAYMAX RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 4
CARILEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORK MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
KCI USA, INC
  SUBSTANTIALLY EQUIVALENT 2
KCI USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
KCI USA, INC. (KINETIC CONCEPTS, INC.)
  SUBSTANTIALLY EQUIVALENT 3
KCI, A PART OF 3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
LC MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 4
MEDELA, AG
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE, US LLC
  SUBSTANTIALLY EQUIVALENT 4
NEXA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIMEX MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 12
SMITH & NEPHEW MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STORTFORD MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 2
VR MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 398 398
2017 368 368
2018 422 422
2019 994 994
2020 3664 4406
2021 1350 1350

Device Problems MDRs with this Device Problem Events in those MDRs
Collapse 1146 1888
Adverse Event Without Identified Device or Use Problem 1112 1112
Failure to Charge 712 712
Suction Failure 618 618
Pumping Stopped 591 591
False Alarm 525 525
Insufficient Information 475 475
Defective Alarm 333 333
Obstruction of Flow 246 246
Device Alarm System 240 240
Unexpected Shutdown 213 213
Leak/Splash 147 147
Appropriate Term/Code Not Available 125 125
Suction Problem 114 114
Protective Measures Problem 106 106
Overheating of Device 101 101
Defective Device 89 89
Failure to Power Up 85 85
Failure to Pump 78 78
Device Operates Differently Than Expected 71 71
Improper or Incorrect Procedure or Method 64 64
Battery Problem 52 52
No Pressure 49 49
Electrical /Electronic Property Problem 49 49
Gas Leak 45 45
Device Inoperable 43 43
Pumping Problem 43 43
Defective Component 40 40
Break 39 39
Device Displays Incorrect Message 38 38
Device Emits Odor 37 37
Fluid Leak 35 35
Mechanical Problem 34 34
Loss of or Failure to Bond 33 33
No Audible Alarm 30 30
Pressure Problem 29 29
Loss of Power 26 26
Charging Problem 26 26
Complete Blockage 25 25
Crack 24 24
Use of Device Problem 24 24
Infusion or Flow Problem 23 23
Air Leak 23 23
Power Problem 22 22
Noise, Audible 20 20
Alarm Not Visible 20 20
Decrease in Suction 20 20
Melted 18 18
Smoking 18 18
Nonstandard Device 16 16
No Apparent Adverse Event 16 16
Thermal Decomposition of Device 15 15
Material Integrity Problem 14 14
Fire 13 13
Patient-Device Incompatibility 12 12
Electrical Power Problem 11 11
Decrease in Pressure 11 11
Partial Blockage 11 11
Therapeutic or Diagnostic Output Failure 11 11
Temperature Problem 10 10
Image Display Error/Artifact 10 10
Display or Visual Feedback Problem 9 9
Difficult to Remove 8 8
Excessive Heating 8 8
Electrical Shorting 7 7
Connection Problem 7 7
Sparking 6 6
Circuit Failure 6 6
Delivered as Unsterile Product 6 6
Loose or Intermittent Connection 5 5
No Display/Image 5 5
Failure to Run on Battery 5 5
Power Conditioning Problem 5 5
Application Program Problem 5 5
Unexpected Therapeutic Results 5 5
Material Deformation 5 5
Output Problem 4 4
Electronic Property Issue 4 4
Self-Activation or Keying 4 4
Dent in Material 4 4
Low Battery 4 4
Component Missing 4 4
Increase in Pressure 4 4
Premature Discharge of Battery 4 4
Material Disintegration 4 4
Computer Software Problem 4 4
Patient Device Interaction Problem 4 4
Component Misassembled 4 4
Incomplete or Inadequate Connection 3 3
Component Falling 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Product Quality Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Inadequate User Interface 2 2
Difficult to Open or Close 2 2
Electrical Overstress 2 2
Failure to Shut Off 2 2
Detachment of Device or Device Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2168 2910
No Consequences Or Impact To Patient 1849 2591
No Known Impact Or Consequence To Patient 1205 1205
No Patient Involvement 639 979
Unspecified Infection 551 551
Injury 318 318
Foreign Body In Patient 118 118
Hemorrhage/Bleeding 117 117
Necrosis 104 104
No Information 97 97
Tissue Breakdown 89 89
Wound Dehiscence 88 88
Insufficient Information 80 80
Bacterial Infection 71 72
Tissue Damage 70 70
Fungal Infection 65 65
Impaired Healing 61 61
Post Operative Wound Infection 59 59
No Code Available 41 41
Blood Loss 35 35
Pain 31 31
Zonular Dehiscence 27 27
Fistula 25 25
Failure of Implant 23 23
Abscess 21 21
Death 21 21
Skin Irritation 18 18
Hematoma 16 16
Purulent Discharge 15 15
Blister 15 15
Device Embedded In Tissue or Plaque 13 13
Reaction 13 13
Cellulitis 13 13
Swelling 13 13
Erythema 12 12
Fluid Discharge 12 12
Inflammation 11 11
Unspecified Tissue Injury 10 10
Swelling/ Edema 9 9
Skin Infection 9 9
Patient Problem/Medical Problem 9 9
Seroma 8 8
Sepsis 7 7
Rash 7 8
Burn(s) 7 7
Skin Tears 7 7
Discomfort 7 7
Skin Disorders 7 7
Localized Skin Lesion 6 6
Skin Inflammation/ Irritation 6 6
Cyst(s) 6 6
Hypersensitivity/Allergic reaction 6 6
Ulcer 6 6
Skin Discoloration 5 5
Skin Erosion 5 5
Mediastinal Shift 5 5
Local Reaction 5 5
Fever 5 5
Drug Resistant Bacterial Infection 5 5
Not Applicable 5 5
Pressure Sores 5 5
Bowel Perforation 5 5
Electric Shock 4 4
Foreign Body Reaction 4 4
Bone Fracture(s) 4 4
Rupture 4 4
Discharge 3 3
Staphylococcus Aureus 3 3
Itching Sensation 3 3
Laceration(s) 3 3
Exsanguination 3 3
Fall 3 3
Bruise/Contusion 3 3
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 3 3
Contact Dermatitis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abdominal Distention 2 2
Pseudoaneurysm 2 2
Cardiac Perforation 2 2
Skin Inflammation 2 2
Complaint, Ill-Defined 2 2
Post Traumatic Wound Infection 2 2
Abrasion 2 2
Anemia 2 2
Gangrene 2 2
High Blood Pressure/ Hypertension 2 2
Irritation 2 2
Necrosis Of Flap Tissue 2 2
Sinus Perforation 2 2
Thrombus 2 2
Ulceration 1 1
Urinary Tract Infection 1 1
Blurred Vision 1 1
Burning Sensation 1 1
Toxemia 1 1
Hernia 1 1
Therapeutic Response, Decreased 1 1
Nerve Damage 1 1
Muscle Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jul-10-2020
2 KCI USA, INC. II Jul-10-2020
3 KCI USA, INC. II May-30-2017
4 KCI USA, INC. II Jan-06-2016
5 Medela Inc II Jan-02-2020
6 Medela Inc II Jul-23-2018
7 Smith & Nephew, Inc. II Jan-18-2017
8 Smith & Nephew, Inc. II Sep-20-2016
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