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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 61 61
Material Separation 55 55
Adverse Event Without Identified Device or Use Problem 46 46
Fluid/Blood Leak 39 39
Fracture 36 36
Leak/Splash 34 34
Detachment of Device or Device Component 29 29
Sharp Edges 26 26
Material Puncture/Hole 19 19
Complete Blockage 12 12
Unsealed Device Packaging 11 11
Tear, Rip or Hole in Device Packaging 10 10
Material Split, Cut or Torn 9 9
Material Twisted/Bent 8 8
Obstruction of Flow 7 7
Defective Component 6 6
Device Dislodged or Dislocated 6 6
Device Handling Problem 5 5
Migration 4 4
Crack 4 4
Contamination 3 3
Product Quality Problem 3 3
Difficult to Remove 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
Device Contamination with Chemical or Other Material 2 2
Difficult to Insert 2 2
Restricted Flow rate 2 2
Decrease in Suction 2 2
Component Misassembled 2 2
Appropriate Term/Code Not Available 2 2
Suction Failure 2 2
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
Disconnection 1 1
Entrapment of Device 1 1
Loss of or Failure to Bond 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Stretched 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 260 260
No Consequences Or Impact To Patient 98 99
Insufficient Information 29 29
Pneumothorax 15 15
Unspecified Infection 14 14
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 4 4
Radiation Exposure, Unintended 3 3
Skin Inflammation 3 3
Bacterial Infection 3 3
Pleural Empyema 3 3
No Patient Involvement 3 3
No Information 3 3
Obstruction/Occlusion 2 2
Inflammation 2 2
Irritation 2 2
Death 2 2
Device Embedded In Tissue or Plaque 2 2
Pressure Sores 2 2
Loss of consciousness 1 1
Pulmonary Insufficiency 1 1
Tissue Damage 1 1
Electrolyte Imbalance 1 1
Decreased Respiratory Rate 1 1
Ascites 1 1
Blood Loss 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
Superficial (First Degree) Burn 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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