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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable transprostatic tissue retractor system
Definition The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product CodePEW
Regulation Number 876.5530
Device Class 2


Premarket Reviews
ManufacturerDecision
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 47 47
2020 65 65
2021 50 50
2022 55 55
2023 52 52
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 150 150
Fracture 84 84
Misfire 12 12
Break 10 10
Failure to Fire 6 6
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Detachment of Device or Device Component 1 1
Compatibility Problem 1 1
Calcified 1 1
Crack 1 1
Failure to Cut 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
Hematoma 40 40
Hematuria 29 29
Urinary Tract Infection 28 28
No Known Impact Or Consequence To Patient 27 27
Pain 19 19
Hemorrhage/Bleeding 18 18
Sepsis 16 16
Insufficient Information 11 11
Urinary Retention 10 10
Low Blood Pressure/ Hypotension 7 7
Death 7 7
Foreign Body In Patient 6 6
Renal Failure 5 5
No Consequences Or Impact To Patient 4 4
Unspecified Infection 3 3
Cardiac Arrest 3 3
Dysuria 3 3
Needle Stick/Puncture 3 3
No Code Available 3 3
Device Embedded In Tissue or Plaque 2 2
Heart Failure/Congestive Heart Failure 2 2
Blood Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Syncope/Fainting 2 2
Pulmonary Embolism 2 2
Bacterial Infection 2 2
Failure of Implant 2 2
Incontinence 2 2
Hypoxia 1 1
Inflammation 1 1
Rash 1 1
Stenosis 1 1
Urinary Frequency 1 1
Electrolyte Imbalance 1 1
Scar Tissue 1 1
Tachycardia 1 1
Erosion 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Syncope 1 1
Abdominal Pain 1 1
Stroke/CVA 1 1
Infarction, Cerebral 1 1
Edema 1 1
Extravasation 1 1
Fever 1 1
Gangrene 1 1
Granuloma 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Embolism/Embolus 1 1
Abdominal Distention 1 1
Pseudoaneurysm 1 1
No Patient Involvement 1 1
Hyponatremia 1 1
Drug Resistant Bacterial Infection 1 1
Urinary Incontinence 1 1
Swelling/ Edema 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Neotract Inc II Aug-05-2022
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