TPLC - Total Product Life Cycle

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Device	hydrogel spacer
Regulation Description	Absorbable perirectal 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
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	1171	1171
Adverse Event Without Identified Device or Use Problem	358	358
Malposition of Device	130	130
Migration	56	56
Material Integrity Problem	55	55
Obstruction of Flow	34	34
Defective Device	29	29
Device Contamination with Chemical or Other Material	22	22
Inadequacy of Device Shape and/or Size	16	16
Use of Device Problem	15	15
No Apparent Adverse Event	15	15
Patient Device Interaction Problem	9	9
Material Deformation	9	9
Appropriate Term/Code Not Available	6	6
Activation, Positioning or Separation Problem	4	4
Contamination	4	4
Unsealed Device Packaging	3	3
Device Ingredient or Reagent Problem	2	2
Device-Device Incompatibility	2	2
Break	2	2
Deflation Problem	2	2
Positioning Failure	2	2
Infusion or Flow Problem	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
Insufficient Information	1	1
Precipitate in Device or Device Ingredient	1	1
Difficult or Delayed Positioning	1	1
Packaging Problem	1	1
Poor Visibility	1	1
Product Quality Problem	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	895	895
Pain	339	339
Discomfort	199	199
Abscess	160	160
Inflammation	141	141
Fistula	138	138
Hemorrhage/Bleeding	133	133
Ulcer	122	122
Fluid Discharge	118	118
Unspecified Infection	108	108
Urinary Retention	96	96
Constipation	84	84
Fever	71	71
Perforation	60	60
Insufficient Information	52	52
Swelling/ Edema	50	50
Diarrhea	38	38
Hypersensitivity/Allergic reaction	38	38
Dysuria	30	30
Urinary Frequency	28	28
Cramp(s) /Muscle Spasm(s)	23	23
Necrosis	23	23
Unspecified Kidney or Urinary Problem	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Micturition Urgency	17	17
Embolism/Embolus	17	17
Hematoma	17	17
Chills	16	16
Erosion	16	16
Loss of consciousness	16	16
Syncope/Fainting	16	16
Urinary Tract Infection	16	16
Hematuria	15	15
Purulent Discharge	15	15
Nausea	14	14
Low Blood Pressure/ Hypotension	14	14
Rash	14	14
Obstruction/Occlusion	13	13
Burning Sensation	13	13
Abdominal Pain	13	13
Skin Inflammation/ Irritation	12	12
Fecal Incontinence	12	12
Bacterial Infection	12	12
Vomiting	12	12
Unspecified Tissue Injury	11	11
Sepsis	11	11
Cardiac Arrest	11	11
Urinary Incontinence	10	10
Dizziness	9	9
Itching Sensation	9	9

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