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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 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 13
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 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1212 1212
Collapse 1148 1890
Failure to Charge 671 671
Suction Failure 639 639
Pumping Stopped 590 590
False Alarm 525 525
Insufficient Information 396 396
Defective Alarm 335 335
Obstruction of Flow 249 249
Unexpected Shutdown 215 215
Device Alarm System 212 212
Leak/Splash 133 133
Overheating of Device 116 116
Improper or Incorrect Procedure or Method 113 113
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 Leak 48 48
Electrical /Electronic Property Problem 48 48
Device Emits Odor 43 43
Pumping Problem 43 43
Loss of or Failure to Bond 41 41
Defective Component 38 38
Fluid Leak 37 37
Device Operates Differently Than Expected 36 36
Break 35 35
No Audible Alarm 34 34
Mechanical Problem 34 34
Pressure Problem 27 27
Use of Device Problem 27 27
Complete Blockage 25 25
Crack 25 25
Alarm Not Visible 23 23
Infusion or Flow Problem 23 23
Device Inoperable 22 22
Charging Problem 21 21
Smoking 20 20
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
Nonstandard Device 15 15
Material Integrity Problem 15 15
Fire 14 14
Air Leak 14 14
Thermal Decomposition of Device 14 14
Decrease in Pressure 13 13
Therapeutic or Diagnostic Output Failure 11 11
Electrical Power Problem 11 11
Temperature Problem 10 10
Patient-Device Incompatibility 10 10
Image Display Error/Artifact 10 10
Partial Blockage 10 10
Display or Visual Feedback Problem 9 9
Excessive Heating 8 8
Delivered as Unsterile Product 7 7
Electrical Shorting 7 7
Material Deformation 5 5
Output Problem 5 5
Application Program Problem 5 5
Connection Problem 5 5
Sparking 5 5
Unexpected Therapeutic Results 5 5
Loose or Intermittent Connection 5 5
Failure to Run on Battery 5 5
Difficult to Remove 5 5
No Display/Image 5 5
Premature Discharge of Battery 5 5
Patient Device Interaction Problem 5 5
Component Misassembled 4 4
Incomplete or Inadequate Connection 4 4
Material Disintegration 4 4
Computer Software Problem 4 4
Increase in Pressure 4 4
Device Difficult to Setup or Prepare 4 4
Dent in Material 4 4
Electronic Property Issue 4 4
Device Contamination with Chemical or Other Material 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Increase in Suction 3 3
Self-Activation or Keying 3 3
Product Quality Problem 3 3
Power Conditioning Problem 3 3
Contamination 3 3
Material Discolored 3 3
Circuit Failure 3 3
Detachment Of Device Component 2 2
Delayed Alarm 2 2
Failure To Adhere Or Bond 2 2
Entrapment of Device 2 2
Failure to Reset 2 2
Vibration 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2221 2963
No Consequences Or Impact To Patient 1829 2571
No Known Impact Or Consequence To Patient 1038 1038
No Patient Involvement 637 977
Unspecified Infection 540 540
Injury 312 312
Hemorrhage/Bleeding 134 134
Bacterial Infection 110 111
Tissue Breakdown 110 110
Necrosis 106 106
Foreign Body In Patient 105 105
Insufficient Information 103 103
Wound Dehiscence 95 95
Fungal Infection 79 79
No Information 75 75
Post Operative Wound Infection 57 57
Tissue Damage 48 48
Impaired Healing 44 44
Pain 38 38
No Code Available 33 33
Failure of Implant 28 28
Zonular Dehiscence 27 27
Device Embedded In Tissue or Plaque 27 27
Blood Loss 24 24
Abscess 22 22
Hematoma 19 19
Fistula 19 19
Cellulitis 17 17
Blister 17 17
Skin Disorders 16 16
Sepsis 16 16
Skin Irritation 16 16
Fluid Discharge 15 15
Swelling/ Edema 13 13
Death 13 13
Purulent Discharge 11 11
Swelling 11 11
Unspecified Tissue Injury 11 11
Skin Infection 9 9
Patient Problem/Medical Problem 9 9
Reaction 9 9
Skin Inflammation/ Irritation 8 8
Seroma 8 8
Rash 8 9
Inflammation 8 8
Fever 8 8
Fall 7 7
Erythema 7 7
Burn(s) 7 7
Ulcer 7 7
Laceration(s) 6 6
Skin Discoloration 6 6
Cyst(s) 6 6
Hypersensitivity/Allergic reaction 6 6
Drug Resistant Bacterial Infection 6 6
Localized Skin Lesion 6 6
Skin Tears 6 6
Mediastinal Shift 5 5
Discomfort 5 5
Not Applicable 5 5
Skin Erosion 5 5
Local Reaction 4 4
Rupture 4 4
Foreign Body Reaction 4 4
Bone Fracture(s) 4 4
Bruise/Contusion 4 4
Full thickness (Third Degree) Burn 4 4
Osteomyelitis 4 4
Pressure Sores 4 4
Electric Shock 4 4
Bowel Perforation 4 4
Partial thickness (Second Degree) Burn 3 3
Contact Dermatitis 3 3
High Blood Pressure/ Hypertension 3 3
Itching Sensation 3 3
Burning Sensation 3 3
Tachycardia 2 2
Sinus Perforation 2 2
Necrosis Of Flap Tissue 2 2
Gangrene 2 2
Abrasion 2 2
Anemia 2 2
Exsanguination 2 2
Ecchymosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Muscle/Tendon Damage 2 2
Rectal Anastomotic Leakage 2 2
Limb Fracture 2 2
Cardiac Perforation 2 2
Abdominal Distention 2 2
Hip Fracture 2 2
Skin Inflammation 2 2
Sweating 1 1
Tooth Fracture 1 1
Nipple Ulceration 1 1
Inadequate Pain Relief 1 1
Perforation of Esophagus 1 1
Fracture, Arm 1 1
Sedation 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 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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