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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
  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
2019 85 85
2020 126 126
2021 272 272
2022 387 387
2023 327 327
2024 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Problem 963 963
Adverse Event Without Identified Device or Use Problem 281 281
Material Integrity Problem 25 25
Defective Device 23 23
Device Contamination with Chemical or Other Material 15 15
Obstruction of Flow 14 14
Appropriate Term/Code Not Available 12 12
Migration 11 11
Inadequacy of Device Shape and/or Size 10 10
Use of Device Problem 7 7
Material Deformation 6 6
Insufficient Information 6 6
Connection Problem 2 2
Device-Device Incompatibility 2 2
Contamination 2 2
Fluid/Blood Leak 2 2
Loose or Intermittent Connection 2 2
Unsealed Device Packaging 2 2
Product Quality Problem 1 1
Leak/Splash 1 1
Packaging Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 547 547
Pain 285 285
Discomfort 175 175
Fistula 124 124
Abscess 112 112
Hemorrhage/Bleeding 104 104
Fluid Discharge 98 98
Ulcer 90 90
Inflammation 90 90
Unspecified Infection 77 77
No Consequences Or Impact To Patient 70 70
Urinary Retention 59 59
Constipation 56 56
Perforation 49 49
Fever 49 49
Insufficient Information 35 35
Hypersensitivity/Allergic reaction 31 31
Swelling/ Edema 30 30
Diarrhea 28 28
Urinary Frequency 25 25
No Code Available 18 18
Injury 16 16
Dysuria 16 16
Micturition Urgency 15 15
Necrosis 15 15
Cramp(s) /Muscle Spasm(s) 14 14
Obstruction/Occlusion 13 13
Urinary Tract Infection 13 13
Hematoma 13 13
Syncope/Fainting 12 12
Unspecified Kidney or Urinary Problem 12 12
No Known Impact Or Consequence To Patient 11 11
Nausea 11 11
Rash 10 10
Erosion 10 10
Burning Sensation 10 10
Chills 9 9
Loss of consciousness 9 9
Hematuria 9 9
Skin Inflammation/ Irritation 9 9
Unspecified Tissue Injury 9 9
Fecal Incontinence 8 8
Cardiac Arrest 8 8
Abdominal Pain 8 8
Purulent Discharge 8 8
Dyspnea 8 8
Swelling 8 8
Low Blood Pressure/ Hypotension 8 8
Sepsis 7 7
Urinary Incontinence 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Embolism/Embolus 7 7
Dizziness 7 7
Vomiting 6 6
Therapeutic Effects, Unexpected 6 6
Itching Sensation 6 6
Ischemia 5 5
Shock 5 5
Pulmonary Embolism 5 5
Diaphoresis 4 4
Diminished Pulse Pressure 4 4
Confusion/ Disorientation 3 3
Ulceration 3 3
Fibrosis 3 3
Tachycardia 3 3
Renal Failure 3 3
Hypoxia 3 3
Incontinence 3 3
High Blood Pressure/ Hypertension 3 3
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Local Reaction 2 2
Tissue Damage 2 2
Adhesion(s) 2 2
Anemia 2 2
Arrhythmia 2 2
Bruise/Contusion 2 2
Chest Pain 2 2
Bacterial Infection 2 2
Edema 2 2
Decreased Appetite 2 2
Anxiety 2 2
Weight Changes 2 2
Vaso-Vagal Response 2 2
Bowel Perforation 2 2
Needle Stick/Puncture 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Abdominal Distention 1 1
Test Result 1 1
Vascular Dissection 1 1
Patient Problem/Medical Problem 1 1
Depression 1 1
Disability 1 1
Numbness 1 1
Electrolyte Imbalance 1 1
Urticaria 1 1
Pressure Sores 1 1
Localized Skin Lesion 1 1

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