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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 2
3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 4
4L HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALLEVA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ALLEVA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
APPLIED TISSUE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 3
BAYMAX RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
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 2
KCI USA, INC
  SUBSTANTIALLY EQUIVALENT 2
KCI USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
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
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 11
SMITH AND NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 422 422
2019 994 994
2020 3664 4406
2021 1422 1422
2022 258 258
2023 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1206 1206
Collapse 1148 1890
Suction Failure 640 640
Failure to Charge 639 639
Pumping Stopped 583 583
False Alarm 527 527
Insufficient Information 344 344
Defective Alarm 330 330
Obstruction of Flow 250 250
Unexpected Shutdown 215 215
Device Alarm System 189 189
Improper or Incorrect Procedure or Method 134 134
Leak/Splash 121 121
Overheating of Device 111 111
Protective Measures Problem 108 108
Suction Problem 97 97
Defective Device 90 90
Failure to Pump 76 76
Failure to Power Up 74 74
No Pressure 48 48
Gas/Air Leak 48 48
Battery Problem 47 47
Device Emits Odor 42 42
Pumping Problem 42 42
Loss of or Failure to Bond 41 41
Appropriate Term/Code Not Available 40 40
Electrical /Electronic Property Problem 39 39
Defective Component 35 35
Fluid/Blood Leak 35 35
Mechanical Problem 34 34
No Audible Alarm 33 33
Break 32 32
Use of Device Problem 28 28
Crack 25 25
Complete Blockage 25 25
Alarm Not Visible 23 23
Infusion or Flow Problem 23 23
Pressure Problem 21 21
Decrease in Suction 17 17
Melted 17 17
No Apparent Adverse Event 16 16
Noise, Audible 16 16
Nonstandard Device 15 15
Smoking 15 15
Material Integrity Problem 15 15
Power Problem 13 13
Device Displays Incorrect Message 13 13
Charging Problem 12 12
Fire 11 11
Electrical Power Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Decrease in Pressure 11 11
Image Display Error/Artifact 10 10
Partial Blockage 9 9
Display or Visual Feedback Problem 9 9
Temperature Problem 9 9
Thermal Decomposition of Device 9 9
Excessive Heating 8 8
Output Problem 7 7
Delivered as Unsterile Product 7 7
Complete Loss of Power 6 6
Electrical Shorting 6 6
Loss of Power 6 6
Patient Device Interaction Problem 5 5
Application Program Problem 5 5
Material Deformation 5 5
Failure to Run on Battery 5 5
No Display/Image 5 5
Sparking 5 5
Unexpected Therapeutic Results 5 5
Patient-Device Incompatibility 4 4
Material Disintegration 4 4
Difficult to Remove 4 4
Device Difficult to Setup or Prepare 4 4
Increase in Pressure 4 4
Premature Discharge of Battery 4 4
Connection Problem 4 4
Component Misassembled 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
Computer Software Problem 4 4
Loose or Intermittent Connection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Low Audible Alarm 3 3
Detachment of Device or Device Component 3 3
Self-Activation or Keying 3 3
Unintended Electrical Shock 3 3
Contamination 3 3
Material Discolored 3 3
Power Conditioning Problem 2 2
Product Quality Problem 2 2
Device Fell 2 2
Activation Failure 2 2
Key or Button Unresponsive/not Working 2 2
Failure to Seal 2 2
Contamination /Decontamination Problem 2 2
Increase in Suction 2 2
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2230 2972
No Consequences Or Impact To Patient 1808 2550
No Known Impact Or Consequence To Patient 897 897
No Patient Involvement 637 977
Unspecified Infection 505 505
Injury 296 296
Hemorrhage/Bleeding 132 132
Bacterial Infection 124 125
Tissue Breakdown 113 113
Insufficient Information 109 109
Necrosis 103 103
Foreign Body In Patient 96 96
Wound Dehiscence 95 95
Fungal Infection 91 91
Post Operative Wound Infection 57 57
No Information 45 45
Pain 40 40
Impaired Healing 37 37
Device Embedded In Tissue or Plaque 34 34
Failure of Implant 28 28
Zonular Dehiscence 27 27
Abscess 25 25
Tissue Damage 22 22
No Code Available 21 21
Cellulitis 19 19
Blister 19 19
Fistula 19 19
Skin Disorders 18 18
Hematoma 17 17
Sepsis 16 16
Skin Irritation 15 15
Swelling/ Edema 14 14
Fluid Discharge 13 13
Blood Loss 13 13
Death 12 12
Unspecified Tissue Injury 11 11
Fever 10 10
Skin Inflammation/ Irritation 10 10
Patient Problem/Medical Problem 9 9
Purulent Discharge 9 9
Skin Infection 9 9
Inflammation 8 8
Osteomyelitis 8 8
Rash 8 9
Seroma 8 8
Fall 7 7
Burn(s) 7 7
Drug Resistant Bacterial Infection 7 7
Laceration(s) 6 6
Skin Discoloration 6 6
Cyst(s) 6 6
Swelling 6 6
Localized Skin Lesion 6 6
Hypersensitivity/Allergic reaction 6 6
Discomfort 5 5
Foreign Body Reaction 5 5
Mediastinal Shift 5 5
Erythema 4 4
Rupture 4 4
Skin Tears 4 4
Local Reaction 4 4
Bruise/Contusion 4 4
Electric Shock 3 3
Exsanguination 3 3
Skin Erosion 3 3
Hernia 3 3
Pressure Sores 3 3
Partial thickness (Second Degree) Burn 3 3
High Blood Pressure/ Hypertension 3 3
Itching Sensation 3 3
Bowel Perforation 3 3
Bone Fracture(s) 3 3
Ulcer 3 3
Contact Dermatitis 3 3
Burning Sensation 3 3
Full thickness (Third Degree) Burn 3 3
Limb Fracture 2 2
Scar Tissue 2 2
Hip Fracture 2 2
Ischemia 2 2
Anemia 2 2
Lethargy 2 2
Rectal Anastomotic Leakage 2 2
Muscle/Tendon Damage 2 2
Necrosis Of Flap Tissue 2 2
Skin Burning Sensation 2 2
Abrasion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Gangrene 2 2
Sinus Perforation 2 2
Ecchymosis 2 2
Edema 1 1
Hyperglycemia 1 1
Pseudoaneurysm 1 1
Urinary Tract Infection 1 1
Nipple Ulceration 1 1
Skin Inflammation 1 1
Low Oxygen Saturation 1 1
Low Blood Pressure/ Hypotension 1 1
Eczema 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 Medela Inc II Jan-02-2020
4 Medela Inc II Jul-23-2018
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