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
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	301	301
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
Appropriate Term/Code Not Available	12	12
Use of Device Problem	8	8
Material Deformation	7	7
Insufficient Information	6	6
Device-Device Incompatibility	2	2
Malposition of Device	2	2
Unsealed Device Packaging	2	2
Contamination	2	2
Device Dislodged or Dislocated	2	2
Connection Problem	2	2
Loose or Intermittent Connection	2	2
Fluid/Blood Leak	2	2
Leak/Splash	1	1
Device Contaminated During Manufacture or Shipping	1	1
Off-Label Use	1	1
Patient Device Interaction Problem	1	1
Packaging Problem	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	606	606
Pain	297	297
Discomfort	183	183
Fistula	133	133
Abscess	120	120
Hemorrhage/Bleeding	111	111
Fluid Discharge	106	106
Inflammation	97	97
Ulcer	93	93
Unspecified Infection	82	82
No Consequences Or Impact To Patient	70	70
Urinary Retention	65	65
Constipation	63	63
Fever	53	53
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
Dysuria	17	17
Micturition Urgency	17	17
Injury	16	16
Necrosis	16	16
Obstruction/Occlusion	15	15
Unspecified Kidney or Urinary Problem	15	15
Cramp(s) /Muscle Spasm(s)	14	14
Urinary Tract Infection	14	14
Hematoma	13	13
Syncope/Fainting	13	13
Nausea	12	12
Hematuria	12	12
Loss of consciousness	12	12
Skin Inflammation/ Irritation	11	11
Rash	11	11
Erosion	11	11
No Known Impact Or Consequence To Patient	11	11
Low Blood Pressure/ Hypotension	11	11
Chills	10	10
Burning Sensation	10	10
Unspecified Tissue Injury	9	9
Cardiac Arrest	9	9
Embolism/Embolus	9	9
Abdominal Pain	9	9
Fecal Incontinence	9	9
Pulmonary Embolism	8	8
Purulent Discharge	8	8
Dizziness	8	8
Dyspnea	8	8

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