• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1155 1155
Collapse 1147 1889
Suction Failure 639 639
Failure to Charge 581 581
Pumping Stopped 561 561
False Alarm 528 528
Insufficient Information 292 292
Defective Alarm 288 288
Obstruction of Flow 252 252
Unexpected Shutdown 214 214
Improper or Incorrect Procedure or Method 164 164
Device Alarm System 164 164
Leak/Splash 117 117
Protective Measures Problem 108 108
Suction Problem 96 96
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
Device Emits Odor 41 41
Loss of or Failure to Bond 41 41
Fluid/Blood Leak 37 37
Pumping Problem 36 36
Defective Component 35 35
No Audible Alarm 33 33
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 21 21
Pressure Problem 20 20
Decrease in Suction 17 17
Melted 17 17
Noise, Audible 16 16
Material Integrity Problem 15 15
Mechanical Problem 15 15
Smoking 15 15
Fire 14 14
Appropriate Term/Code Not Available 14 14
No Apparent Adverse Event 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
Excessive Heating 7 7
Partial Blockage 7 7
No Display/Image 6 6
Complete Loss of Power 6 6
Incomplete or Inadequate Connection 5 5
Patient Device Interaction Problem 5 5
Material Deformation 5 5
Temperature Problem 5 5
Arcing 5 5
Application Program Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Failure to Run on Battery 5 5
Off-Label Use 5 5
Unexpected Therapeutic Results 5 5
Difficult to Remove 5 5
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
Electrical Shorting 4 4
Detachment of Device or Device Component 4 4
Sparking 4 4
Patient-Device Incompatibility 4 4
Dent in Material 4 4
Failure to Seal 4 4
Activation Failure 3 3
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
Increase in Suction 2 2
Product Quality Problem 2 2
Power Conditioning Problem 2 2
Disconnection 2 2
Delayed Alarm 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2248 2990
No Consequences Or Impact To Patient 1634 2376
No Known Impact Or Consequence To Patient 833 833
No Patient Involvement 626 966
Unspecified Infection 478 478
Injury 272 272
Bacterial Infection 128 129
Hemorrhage/Bleeding 123 123
Insufficient Information 115 115
Tissue Breakdown 103 103
Fungal Infection 95 95
Foreign Body In Patient 95 95
Necrosis 95 95
Wound Dehiscence 91 91
Post Operative Wound Infection 59 59
Device Embedded In Tissue or Plaque 50 50
Pain 40 40
Impaired Healing 39 39
No Information 33 33
Zonular Dehiscence 27 27
Failure of Implant 26 26
Abscess 24 24
Hematoma 19 19
Blister 19 19
Skin Disorders 18 18
No Code Available 18 18
Fistula 18 18
Sepsis 18 18
Cellulitis 17 17
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
Fall 7 7
Burn(s) 7 7
Seroma 7 7
Rash 7 8
Drug Resistant Bacterial Infection 7 7
Localized Skin Lesion 6 6
Hypersensitivity/Allergic reaction 6 6
Laceration(s) 6 6
Erythema 6 6
Cyst(s) 6 6
Foreign Body Reaction 6 6
Swelling 5 5
Rupture 5 5
Mediastinal Shift 5 5
Discomfort 5 5
Skin Tears 4 4
Ulcer 4 4
Hernia 3 3
Skin Discoloration 3 3
Burning Sensation 3 3
Local Reaction 3 3
Exsanguination 3 3
Bruise/Contusion 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
Abrasion 2 2
Anemia 2 2
Ecchymosis 2 2
Gangrene 2 2
Ischemia 2 2
Itching Sensation 2 2
High Blood Pressure/ Hypertension 2 2
Skin Erosion 2 2
Sinus Perforation 2 2
Pressure Sores 2 2
Anxiety 1 1
Distress 1 1
Discharge 1 1
Ulceration 1 1
Urinary Tract Infection 1 1
Toxemia 1 1
Low Blood Pressure/ Hypotension 1 1
Liver Damage/Dysfunction 1 1
Nausea 1 1
Scar Tissue 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 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
-
-