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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, suction, patient care
Product CodeDWM
Regulation Number 870.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
BEARPAC MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCKET MEDICAL PLC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2019 57 57
2020 68 68
2021 143 143
2022 62 62
2023 108 108
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 63 63
Material Separation 55 55
Adverse Event Without Identified Device or Use Problem 47 47
Fluid/Blood Leak 44 44
Fracture 36 36
Leak/Splash 35 35
Detachment of Device or Device Component 30 30
Sharp Edges 26 26
Material Puncture/Hole 19 19
Complete Blockage 13 13
Unsealed Device Packaging 13 13
Tear, Rip or Hole in Device Packaging 10 10
Material Split, Cut or Torn 9 9
Material Twisted/Bent 8 8
Device Handling Problem 7 7
Obstruction of Flow 7 7
Defective Component 6 6
Device Dislodged or Dislocated 6 6
Migration 5 5
Crack 4 4
Product Quality Problem 4 4
Difficult to Remove 3 3
Contamination 3 3
Device Contamination with Chemical or Other Material 3 3
Device Markings/Labelling Problem 3 3
Separation Failure 3 3
Defective Device 2 2
Component Missing 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Restricted Flow rate 2 2
Decrease in Suction 2 2
Loose or Intermittent Connection 2 2
Difficult to Insert 2 2
Component Misassembled 2 2
Suction Failure 2 2
Appropriate Term/Code Not Available 2 2
Air/Gas in Device 1 1
Device Fell 1 1
Physical Resistance/Sticking 1 1
Patient Device Interaction Problem 1 1
Mechanical Jam 1 1
No Flow 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Migration or Expulsion of Device 1 1
Stretched 1 1
Disconnection 1 1
Entrapment of Device 1 1
Loss of or Failure to Bond 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Suction Problem 1 1
Malposition of Device 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
No Consequences Or Impact To Patient 98 99
Insufficient Information 32 32
Pneumothorax 18 18
Unspecified Infection 15 15
Pain 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Foreign Body In Patient 11 11
No Code Available 9 9
No Known Impact Or Consequence To Patient 8 8
Cellulitis 7 7
Peritonitis 5 5
Discomfort 5 5
No Patient Involvement 3 3
Skin Inflammation 3 3
Bacterial Infection 3 3
Pleural Empyema 3 3
Radiation Exposure, Unintended 3 3
No Information 3 3
Obstruction/Occlusion 2 2
Device Embedded In Tissue or Plaque 2 2
Inflammation 2 2
Irritation 2 2
Death 2 2
Pressure Sores 2 2
Loss of consciousness 1 1
Pulmonary Insufficiency 1 1
Sepsis 1 1
Tissue Damage 1 1
Electrolyte Imbalance 1 1
Decreased Respiratory Rate 1 1
Ascites 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Vascular Dissection 1 1
Dyspnea 1 1
Pulmonary Emphysema 1 1
Erythema 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Adhesion(s) 1 1
Peeling 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Unspecified Respiratory Problem 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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