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 Code	OVB
Regulation Number	892.5725
Device Class	2

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Problem	1046	1046
Adverse Event Without Identified Device or Use Problem	305	305
Material Integrity Problem	29	29
Defective Device	28	28
Obstruction of Flow	17	17
Device Contamination with Chemical or Other Material	16	16
Inadequacy of Device Shape and/or Size	13	13
Migration	12	12
Use of Device Problem	12	12
Appropriate Term/Code Not Available	12	12
Material Deformation	7	7
Insufficient Information	7	7
Improper or Incorrect Procedure or Method	5	5
Malposition of Device	2	2
Connection Problem	2	2
Fluid/Blood Leak	2	2
Device-Device Incompatibility	2	2
Unsealed Device Packaging	2	2
Contamination	2	2
Device Dislodged or Dislocated	2	2
Loose or Intermittent Connection	2	2
Off-Label Use	1	1
Packaging Problem	1	1
Product Quality Problem	1	1
Missing Value Reason	1	1
Inadequate or Insufficient Training	1	1
Leak/Splash	1	1
Device Contaminated During Manufacture or Shipping	1	1
Patient-Device Incompatibility	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	606	606
Pain	298	298
Discomfort	183	183
Fistula	135	135
Abscess	121	121
Hemorrhage/Bleeding	112	112
Fluid Discharge	106	106
Inflammation	98	98
Ulcer	93	93
Unspecified Infection	83	83
No Consequences Or Impact To Patient	70	70
Urinary Retention	67	67
Constipation	63	63
Fever	54	54
Perforation	51	51
Insufficient Information	42	42
Hypersensitivity/Allergic reaction	36	36
Swelling/ Edema	35	35
Diarrhea	30	30
Urinary Frequency	27	27
No Code Available	18	18
Micturition Urgency	17	17
Dysuria	17	17
Injury	16	16
Necrosis	16	16
Unspecified Kidney or Urinary Problem	15	15
Obstruction/Occlusion	15	15
Urinary Tract Infection	14	14
Cramp(s) /Muscle Spasm(s)	14	14
Nausea	13	13
Hematoma	13	13
Syncope/Fainting	13	13
Hematuria	12	12
Loss of consciousness	12	12
Rash	12	12
Low Blood Pressure/ Hypotension	12	12
Skin Inflammation/ Irritation	11	11
Erosion	11	11
Pulmonary Embolism	11	11
No Known Impact Or Consequence To Patient	11	11
Chills	10	10
Burning Sensation	10	10
Abdominal Pain	9	9
Fecal Incontinence	9	9
Embolism/Embolus	9	9
Unspecified Tissue Injury	9	9
Purulent Discharge	9	9
Cardiac Arrest	9	9
Swelling	8	8
Dizziness	8	8

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