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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 154 154
Fracture 84 84
Break 15 15
Misfire 12 12
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 2 2
Device Dislodged or Dislocated 2 2
Compatibility Problem 1 1
Mechanical Problem 1 1
Crack 1 1
Defective Component 1 1
Failure to Cut 1 1
Activation Failure 1 1
Detachment of Device or Device Component 1 1
Retraction Problem 1 1
Delivered as Unsterile Product 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Calcified 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
Hematoma 41 41
Hematuria 29 29
Urinary Tract Infection 28 28
No Known Impact Or Consequence To Patient 27 27
Hemorrhage/Bleeding 20 20
Pain 19 19
Sepsis 16 16
Insufficient Information 11 11
Urinary Retention 11 11
Death 7 7
Low Blood Pressure/ Hypotension 7 7
Foreign Body In Patient 6 6
Renal Failure 5 5
No Consequences Or Impact To Patient 4 4
No Code Available 3 3
Dysuria 3 3
Cardiac Arrest 3 3
Needle Stick/Puncture 3 3
Unspecified Infection 3 3
Failure of Implant 2 2
Bacterial Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Blood Loss 2 2
Pulmonary Embolism 2 2
Incontinence 2 2
Abdominal Pain 2 2
Unspecified Tissue Injury 2 2
Syncope/Fainting 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Heart Failure/Congestive Heart Failure 2 2
Urinary Frequency 1 1
Cancer 1 1
Granuloma 1 1
Erosion 1 1
Headache 1 1
Pseudoaneurysm 1 1
Hypoxia 1 1
Bruise/Contusion 1 1
Swelling/ Edema 1 1
Extravasation 1 1
Calcium Deposits/Calcification 1 1
Stenosis 1 1
Tachycardia 1 1
Gangrene 1 1
Bradycardia 1 1
Scar Tissue 1 1
Discomfort 1 1
No Patient Involvement 1 1
Fever 1 1

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