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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
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
  SUBSTANTIALLY EQUIVALENT 1
3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 3
4L HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED TISSUE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 3
BAYMAX RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 4
CARILEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CLEAR CHOICE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORK MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
GENADYNE BIOTECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
KCI USA, INC
  SUBSTANTIALLY EQUIVALENT 2
KCI USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
KCI USA, INC. (KINETIC CONCEPTS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
KCI, A PART OF 3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSTONE MEDICAL PRODUCTS (NINGBO) CO LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 4
MEDELA, AG
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 14
SMITH NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STORTFORD MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
VR MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 368 368
2018 422 422
2019 994 994
2020 3664 4406
2021 1422 1422
2022 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1234 1234
Collapse 1148 1890
Failure to Charge 673 673
Suction Failure 639 639
Pumping Stopped 590 590
False Alarm 525 525
Insufficient Information 397 397
Defective Alarm 335 335
Obstruction of Flow 249 249
Unexpected Shutdown 215 215
Device Alarm System 212 212
Leak/Splash 133 133
Improper or Incorrect Procedure or Method 127 127
Overheating of Device 116 116
Protective Measures Problem 107 107
Suction Problem 97 97
Appropriate Term/Code Not Available 96 96
Defective Device 89 89
Failure to Power Up 80 80
Failure to Pump 78 78
Battery Problem 51 51
No Pressure 49 49
Gas/Air Leak 48 48
Electrical /Electronic Property Problem 48 48
Pumping Problem 43 43
Device Emits Odor 43 43
Loss of or Failure to Bond 41 41
Fluid/Blood Leak 38 38
Defective Component 38 38
Device Operates Differently Than Expected 36 36
Break 36 36
No Audible Alarm 35 35
Mechanical Problem 34 34
Use of Device Problem 29 29
Pressure Problem 27 27
Complete Blockage 25 25
Crack 25 25
Alarm Not Visible 24 24
Infusion or Flow Problem 23 23
Device Inoperable 22 22
Smoking 22 22
Charging Problem 21 21
Device Displays Incorrect Message 20 20
Decrease in Suction 19 19
Melted 19 19
Power Problem 18 18
Noise, Audible 17 17
No Apparent Adverse Event 16 16
Loss of Power 16 16
Material Integrity Problem 15 15
Nonstandard Device 15 15
Thermal Decomposition of Device 14 14
Air Leak 14 14
Fire 14 14
Decrease in Pressure 13 13
Electrical Power Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Temperature Problem 10 10
Image Display Error/Artifact 10 10
Partial Blockage 10 10
Patient-Device Incompatibility 10 10
Display or Visual Feedback Problem 9 9
Sparking 8 8
Excessive Heating 8 8
Electrical Shorting 7 7
Delivered as Unsterile Product 7 7
Complete Loss of Power 6 6
Failure to Run on Battery 5 5
Premature Discharge of Battery 5 5
Connection Problem 5 5
Loose or Intermittent Connection 5 5
No Display/Image 5 5
Output Problem 5 5
Unexpected Therapeutic Results 5 5
Material Deformation 5 5
Application Program Problem 5 5
Difficult to Remove 5 5
Patient Device Interaction Problem 5 5
Material Disintegration 4 4
Electronic Property Issue 4 4
Device Contamination with Chemical or Other Material 4 4
Dent in Material 4 4
Arcing 4 4
Incomplete or Inadequate Connection 4 4
Device Difficult to Setup or Prepare 4 4
Increase in Pressure 4 4
Computer Software Problem 4 4
Component Misassembled 4 4
Circuit Failure 3 3
Self-Activation or Keying 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Increase in Suction 3 3
Low Audible Alarm 3 3
Detachment of Device or Device Component 3 3
Contamination 3 3
Material Discolored 3 3
Power Conditioning Problem 3 3
Product Quality Problem 3 3
Unintended Electrical Shock 3 3
Device Handling Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2226 2968
No Consequences Or Impact To Patient 1829 2571
No Known Impact Or Consequence To Patient 1038 1038
No Patient Involvement 637 977
Unspecified Infection 542 542
Injury 312 312
Hemorrhage/Bleeding 142 142
Bacterial Infection 121 122
Tissue Breakdown 116 116
Foreign Body In Patient 110 110
Necrosis 109 109
Insufficient Information 104 104
Wound Dehiscence 96 96
Fungal Infection 87 87
No Information 75 75
Post Operative Wound Infection 58 58
Tissue Damage 48 48
Impaired Healing 45 45
Pain 42 42
No Code Available 33 33
Failure of Implant 29 29
Device Embedded In Tissue or Plaque 28 28
Zonular Dehiscence 27 27
Blood Loss 24 24
Abscess 24 24
Fistula 19 19
Cellulitis 19 19
Hematoma 19 19
Blister 18 18
Sepsis 16 16
Skin Irritation 16 16
Skin Disorders 16 16
Fluid Discharge 15 15
Swelling/ Edema 13 13
Death 13 13
Unspecified Tissue Injury 11 11
Swelling 11 11
Purulent Discharge 11 11
Reaction 9 9
Fever 9 9
Skin Infection 9 9
Skin Inflammation/ Irritation 9 9
Patient Problem/Medical Problem 9 9
Seroma 8 8
Inflammation 8 8
Rash 8 9
Erythema 7 7
Ulcer 7 7
Hypersensitivity/Allergic reaction 7 7
Fall 7 7
Burn(s) 7 7
Cyst(s) 6 6
Osteomyelitis 6 6
Skin Tears 6 6
Localized Skin Lesion 6 6
Skin Discoloration 6 6
Laceration(s) 6 6
Drug Resistant Bacterial Infection 6 6
Discomfort 5 5
Not Applicable 5 5
Foreign Body Reaction 5 5
Skin Erosion 5 5
Mediastinal Shift 5 5
Bowel Perforation 4 4
Bone Fracture(s) 4 4
Bruise/Contusion 4 4
Local Reaction 4 4
Electric Shock 4 4
Full thickness (Third Degree) Burn 4 4
Pressure Sores 4 4
Rupture 4 4
Partial thickness (Second Degree) Burn 4 4
Contact Dermatitis 3 3
High Blood Pressure/ Hypertension 3 3
Burning Sensation 3 3
Itching Sensation 3 3
Exsanguination 3 3
Abrasion 2 2
Gangrene 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Skin Burning Sensation 2 2
Sinus Perforation 2 2
Skin Inflammation 2 2
Ecchymosis 2 2
Necrosis Of Flap Tissue 2 2
Tachycardia 2 2
Cardiac Perforation 2 2
Limb Fracture 2 2
Anemia 2 2
Rectal Anastomotic Leakage 2 2
Muscle/Tendon Damage 2 2
Abdominal Distention 2 2
Hip Fracture 2 2
Fracture, Arm 1 1
Perforation of Esophagus 1 1
Hernia 1 1
Sweating 1 1
Lethargy 1 1
Superficial (First Degree) Burn 1 1
Heart Failure/Congestive Heart Failure 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 Medela Inc II Jan-02-2020
5 Medela Inc II Jul-23-2018
6 Smith & Nephew, Inc. II Jan-18-2017
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