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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 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
Material Separation 55 55
Adverse Event Without Identified Device or Use Problem 47 47
Fluid/Blood Leak 45 45
Fracture 36 36
Leak/Splash 35 35
Detachment of Device or Device Component 32 32
Sharp Edges 27 27
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
Device Handling Problem 8 8
Material Twisted/Bent 8 8
Obstruction of Flow 7 7
Device Dislodged or Dislocated 6 6
Defective Component 6 6
Migration 5 5
Product Quality Problem 4 4
Crack 4 4
Contamination 4 4
Difficult to Remove 3 3
Improper or Incorrect Procedure or Method 3 3
Separation Failure 3 3
Device Markings/Labelling Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Defective Device 2 2
Loose or Intermittent Connection 2 2
Patient-Device Incompatibility 2 2
Restricted Flow rate 2 2
Suction Failure 2 2
Difficult to Insert 2 2
Use of Device Problem 2 2
Component Missing 2 2
Appropriate Term/Code Not Available 2 2
Decrease in Suction 2 2
Component Misassembled 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Information 1 1
Expiration Date Error 1 1
Therapeutic or Diagnostic Output Failure 1 1
Suction Problem 1 1
No Flow 1 1
Mechanical Jam 1 1
Device Fell 1 1
Disconnection 1 1
Physical Resistance/Sticking 1 1
Entrapment of Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 280 280
No Consequences Or Impact To Patient 98 99
Insufficient Information 34 34
Pneumothorax 18 18
Unspecified Infection 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Pain 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 Information 3 3
Pleural Empyema 3 3
Radiation Exposure, Unintended 3 3
Skin Inflammation 3 3
No Patient Involvement 3 3
Bacterial Infection 3 3
Inflammation 2 2
Obstruction/Occlusion 2 2
Irritation 2 2
Death 2 2
Pressure Sores 2 2
Device Embedded In Tissue or Plaque 2 2
Skin Inflammation/ Irritation 1 1
Vascular Dissection 1 1
Pulmonary Emphysema 1 1
Adhesion(s) 1 1
Hematoma 1 1
Blood Loss 1 1
Sepsis 1 1
Electrolyte Imbalance 1 1
Failure of Implant 1 1
Pulmonary Insufficiency 1 1
Pleural Effusion 1 1
Erythema 1 1
Peeling 1 1
Skin Infection 1 1
Dyspnea 1 1
Pneumonia 1 1
Tissue Damage 1 1
Unspecified Respiratory Problem 1 1
Superficial (First Degree) Burn 1 1
Ascites 1 1
Loss of consciousness 1 1
Decreased Respiratory Rate 1 1
Low Blood Pressure/ Hypotension 1 1

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