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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hydrogel spacer
Definition The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.
Product CodeOVB
Regulation Number 892.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
AUGMENIX , INC.
  GRANTED 1
AUGMENIX, INC
  SUBSTANTIALLY EQUIVALENT 1
AUGMENIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPROTECT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PALETTE LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2018 11 11
2019 85 85
2020 126 126
2021 272 272
2022 387 387
2023 327 327
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Problem 945 945
Adverse Event Without Identified Device or Use Problem 283 283
Material Integrity Problem 24 24
Defective Device 23 23
Obstruction of Flow 14 14
Device Contamination with Chemical or Other Material 14 14
Use of Device Problem 13 13
Appropriate Term/Code Not Available 12 12
Migration 10 10
Inadequacy of Device Shape and/or Size 10 10
Insufficient Information 7 7
Improper or Incorrect Procedure or Method 6 6
Material Deformation 6 6
Contamination 4 4
Fluid/Blood Leak 2 2
Loose or Intermittent Connection 2 2
Unsealed Device Packaging 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Device-Device Incompatibility 2 2
Patient-Device Incompatibility 1 1
Product Quality Problem 1 1
Leak/Splash 1 1
Inadequate or Insufficient Training 1 1
Packaging Problem 1 1
Missing Value Reason 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 536 536
Pain 284 284
Discomfort 173 173
Fistula 125 125
Abscess 114 114
Hemorrhage/Bleeding 104 104
Fluid Discharge 93 93
Inflammation 92 92
Ulcer 90 90
Unspecified Infection 80 80
No Consequences Or Impact To Patient 70 70
Urinary Retention 59 59
Constipation 54 54
Fever 50 50
Perforation 48 48
Insufficient Information 34 34
Hypersensitivity/Allergic reaction 31 31
Swelling/ Edema 30 30
Diarrhea 27 27
Urinary Frequency 25 25
No Code Available 18 18
Injury 16 16
Dysuria 15 15
Micturition Urgency 15 15
Necrosis 15 15
Urinary Tract Infection 13 13
Hematoma 13 13
Obstruction/Occlusion 13 13
Syncope/Fainting 12 12
Unspecified Kidney or Urinary Problem 12 12
Cramp(s) /Muscle Spasm(s) 12 12
Nausea 12 12
Rash 11 11
No Known Impact Or Consequence To Patient 11 11
Burning Sensation 10 10
Erosion 10 10
Purulent Discharge 9 9
Chills 9 9
Loss of consciousness 9 9
Hematuria 9 9
Unspecified Tissue Injury 9 9
Skin Inflammation/ Irritation 8 8
Fecal Incontinence 8 8
Dyspnea 8 8
Cardiac Arrest 8 8
Abdominal Pain 8 8
Pulmonary Embolism 8 8
Swelling 8 8
Low Blood Pressure/ Hypotension 8 8
Sepsis 7 7
Urinary Incontinence 7 7
Embolism/Embolus 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Dizziness 6 6
Vomiting 6 6
Therapeutic Effects, Unexpected 6 6
Itching Sensation 6 6
Ischemia 5 5
Shock 5 5
Bacterial Infection 4 4
Ulceration 4 4
Diaphoresis 4 4
Diminished Pulse Pressure 4 4
Confusion/ Disorientation 3 3
Fibrosis 3 3
Vessel Or Plaque, Device Embedded In 3 3
Embolism 3 3
Renal Failure 3 3
Incontinence 3 3
Hypoxia 2 2
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Local Reaction 2 2
Tachycardia 2 2
Tissue Damage 2 2
Edema 2 2
Adhesion(s) 2 2
Anemia 2 2
Arrhythmia 2 2
Bruise/Contusion 2 2
Decreased Appetite 2 2
Foreign Body In Patient 2 2
Weight Changes 2 2
Vaso-Vagal Response 2 2
Anxiety 2 2
Depression 1 1
Disability 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Electrolyte Imbalance 1 1
Urticaria 1 1
Pressure Sores 1 1
Bowel Perforation 1 1
Needle Stick/Puncture 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
Vascular Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-25-2022
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