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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 2
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 5
KCI, A PART OF 3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSTONE MEDICAL PRODUCTS (NINGBO) CO LTD
  SUBSTANTIALLY EQUIVALENT 1
MED WAY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 3
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXA MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PENSAR MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 7
SMITH & NEPHEW MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
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 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1193 1193
Collapse 1147 1889
Suction Failure 652 652
Failure to Charge 581 581
Pumping Stopped 561 561
False Alarm 529 529
Insufficient Information 294 294
Defective Alarm 288 288
Obstruction of Flow 253 253
Unexpected Shutdown 214 214
Improper or Incorrect Procedure or Method 183 183
Device Alarm System 164 164
Leak/Splash 118 118
Protective Measures Problem 108 108
Suction Problem 99 99
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 43 43
Loss of or Failure to Bond 42 42
Device Emits Odor 41 41
Fluid/Blood Leak 38 38
No Audible Alarm 36 36
Pumping Problem 36 36
Defective Component 35 35
Break 31 31
Use of Device Problem 30 30
Alarm Not Visible 24 24
Complete Blockage 24 24
Crack 24 24
Infusion or Flow Problem 23 23
Pressure Problem 20 20
Decrease in Suction 17 17
Melted 17 17
Noise, Audible 17 17
Smoking 16 16
Material Integrity Problem 15 15
Fire 15 15
Mechanical Problem 15 15
Appropriate Term/Code Not Available 14 14
No Apparent Adverse Event 14 14
Power Problem 12 12
Delivered as Unsterile Product 12 12
Therapeutic or Diagnostic Output Failure 12 12
Electrical Power Problem 11 11
Thermal Decomposition of Device 11 11
Decrease in Pressure 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2273 3015
No Consequences Or Impact To Patient 1634 2376
No Known Impact Or Consequence To Patient 833 833
No Patient Involvement 626 966
Unspecified Infection 481 481
Injury 272 272
Bacterial Infection 134 135
Hemorrhage/Bleeding 130 130
Insufficient Information 119 119
Tissue Breakdown 103 103
Fungal Infection 102 102
Necrosis 100 100
Wound Dehiscence 100 100
Foreign Body In Patient 98 98
Post Operative Wound Infection 65 65
Device Embedded In Tissue or Plaque 62 62
Impaired Healing 45 45
Pain 42 42
No Information 33 33
Failure of Implant 29 29
Zonular Dehiscence 27 27
Abscess 26 26
Blister 19 19
Hematoma 19 19
No Code Available 18 18
Sepsis 18 18
Fistula 18 18
Cellulitis 18 18
Skin Disorders 18 18
Skin Irritation 15 15
Skin Inflammation/ Irritation 15 15
Tissue Damage 14 14
Swelling/ Edema 14 14
Fluid Discharge 13 13
Unspecified Tissue Injury 13 13
Fever 10 10
Death 10 10
Purulent Discharge 10 10
Osteomyelitis 9 9
Hypersensitivity/Allergic reaction 9 9
Skin Infection 9 9
Patient Problem/Medical Problem 8 8
Blood Loss 8 8
Inflammation 8 8
Fall 7 7
Rash 7 8
Burn(s) 7 7
Drug Resistant Bacterial Infection 7 7
Seroma 7 7
Cyst(s) 6 6

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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