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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 1
CLEAR CHOICE THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
CLEAR CHOICE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORK MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  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 4
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 3
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 7
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
2019 994 994
2020 3664 4406
2021 1422 1422
2022 258 258
2023 143 143
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1168 1168
Collapse 1147 1889
Suction Failure 650 650
Failure to Charge 581 581
Pumping Stopped 561 561
False Alarm 529 529
Insufficient Information 292 292
Defective Alarm 288 288
Obstruction of Flow 252 252
Unexpected Shutdown 214 214
Improper or Incorrect Procedure or Method 175 175
Device Alarm System 164 164
Leak/Splash 117 117
Protective Measures Problem 108 108
Suction Problem 98 98
Overheating of Device 92 92
Defective Device 89 89
Failure to Power Up 76 76
Failure to Pump 74 74
Gas/Air Leak 48 48
No Pressure 46 46
Battery Problem 42 42
Loss of or Failure to Bond 42 42
Device Emits Odor 41 41
Fluid/Blood Leak 37 37
Pumping Problem 36 36
Defective Component 35 35
No Audible Alarm 34 34
Break 31 31
Use of Device Problem 28 28
Crack 24 24
Complete Blockage 24 24
Infusion or Flow Problem 23 23
Alarm Not Visible 22 22
Pressure Problem 20 20
Noise, Audible 17 17
Decrease in Suction 17 17
Melted 17 17
Mechanical Problem 15 15
Smoking 15 15
Material Integrity Problem 15 15
Appropriate Term/Code Not Available 14 14
No Apparent Adverse Event 14 14
Fire 14 14
Therapeutic or Diagnostic Output Failure 12 12
Power Problem 12 12
Electrical Power Problem 11 11
Electrical /Electronic Property Problem 11 11
Decrease in Pressure 11 11
Delivered as Unsterile Product 11 11
Image Display Error/Artifact 10 10
Display or Visual Feedback Problem 9 9
Thermal Decomposition of Device 9 9
Nonstandard Device 9 9
Charging Problem 9 9
Device Displays Incorrect Message 8 8
Output Problem 7 7
Partial Blockage 7 7
Excessive Heating 7 7
No Display/Image 6 6
Complete Loss of Power 6 6
Patient Device Interaction Problem 5 5
Material Deformation 5 5
Temperature Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Unexpected Therapeutic Results 5 5
Arcing 5 5
Application Program Problem 5 5
Failure to Run on Battery 5 5
Off-Label Use 5 5
Difficult to Remove 5 5
Incomplete or Inadequate Connection 5 5
Failure to Seal 4 4
Increase in Pressure 4 4
Loss of Power 4 4
Device Difficult to Setup or Prepare 4 4
Material Disintegration 4 4
Premature Discharge of Battery 4 4
Computer Software Problem 4 4
Dent in Material 4 4
Electrical Shorting 4 4
Detachment of Device or Device Component 4 4
Sparking 4 4
Patient-Device Incompatibility 4 4
Connection Problem 3 3
Unintended Electrical Shock 3 3
Low Audible Alarm 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Unsealed Device Packaging 3 3
Loose or Intermittent Connection 3 3
Self-Activation or Keying 3 3
Activation Failure 3 3
Key or Button Unresponsive/not Working 2 2
Increase in Suction 2 2
Product Quality Problem 2 2
Power Conditioning Problem 2 2
Disconnection 2 2
Delayed Alarm 2 2
Device Handling Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2260 3002
No Consequences Or Impact To Patient 1634 2376
No Known Impact Or Consequence To Patient 833 833
No Patient Involvement 626 966
Unspecified Infection 479 479
Injury 272 272
Bacterial Infection 131 132
Hemorrhage/Bleeding 124 124
Insufficient Information 116 116
Tissue Breakdown 103 103
Fungal Infection 98 98
Foreign Body In Patient 98 98
Necrosis 96 96
Wound Dehiscence 93 93
Post Operative Wound Infection 61 61
Device Embedded In Tissue or Plaque 57 57
Pain 41 41
Impaired Healing 39 39
No Information 33 33
Failure of Implant 28 28
Zonular Dehiscence 27 27
Abscess 25 25
Hematoma 19 19
Blister 19 19
Skin Disorders 18 18
No Code Available 18 18
Fistula 18 18
Cellulitis 18 18
Sepsis 18 18
Skin Irritation 15 15
Tissue Damage 14 14
Swelling/ Edema 14 14
Fluid Discharge 13 13
Unspecified Tissue Injury 12 12
Skin Inflammation/ Irritation 11 11
Death 10 10
Fever 10 10
Purulent Discharge 9 9
Skin Infection 9 9
Osteomyelitis 9 9
Patient Problem/Medical Problem 8 8
Blood Loss 8 8
Inflammation 8 8
Hypersensitivity/Allergic reaction 8 8
Rash 7 8
Seroma 7 7
Fall 7 7
Burn(s) 7 7
Drug Resistant Bacterial Infection 7 7
Localized Skin Lesion 6 6
Erythema 6 6
Cyst(s) 6 6
Foreign Body Reaction 6 6
Laceration(s) 6 6
Swelling 5 5
Rupture 5 5
Mediastinal Shift 5 5
Discomfort 5 5
Skin Tears 4 4
Ulcer 4 4
Exsanguination 4 4
Bruise/Contusion 3 3
Hernia 3 3
Skin Discoloration 3 3
Burning Sensation 3 3
Local Reaction 3 3
Post Traumatic Wound Infection 3 3
Contact Dermatitis 3 3
Skin Burning Sensation 2 2
Rectal Anastomotic Leakage 2 2
Muscle/Tendon Damage 2 2
Limb Fracture 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Lethargy 2 2
Hip Fracture 2 2
Bowel Perforation 2 2
Partial thickness (Second Degree) Burn 2 2
High Blood Pressure/ Hypertension 2 2
Skin Erosion 2 2
Sinus Perforation 2 2
Pressure Sores 2 2
Abrasion 2 2
Anemia 2 2
Ecchymosis 2 2
Gangrene 2 2
Ischemia 2 2
Itching Sensation 2 2
Intracranial Hemorrhage 1 1
Hyperglycemia 1 1
Hyperplasia 1 1
Granuloma 1 1
Head Injury 1 1
Bone Fracture(s) 1 1
Edema 1 1
Emotional Changes 1 1
Chest Pain 1 1
Ossification 1 1
Abdominal Pain 1 1
Anxiety 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 Smith & Nephew Medical, Ltd. II Apr-18-2024
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