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	2
PALETTE LIFE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Problem	1256	1256
Adverse Event Without Identified Device or Use Problem	410	410
Malposition of Device	230	230
Material Integrity Problem	64	64
Migration	61	61
Obstruction of Flow	42	42
Defective Device	32	32
Device Contamination with Chemical or Other Material	24	24
Use of Device Problem	17	17
Inadequacy of Device Shape and/or Size	17	17
No Apparent Adverse Event	17	17
Appropriate Device Problem Term/Code Not Available	13	13
Material Deformation	11	11
Patient Device Interaction Problem	8	8
Activation, Positioning or Separation Problem	4	4
Device Ingredient or Reagent Problem	4	4
Unsealed Device Packaging	3	3
Contamination	3	3
Device-Device Incompatibility	2	2
Break	2	2
Deflation Problem	2	2
Positioning Failure	2	2
Precipitate in Device or Device Ingredient	2	2
Infusion or Flow Problem	2	2
Device Dislodged or Dislocated	2	2
Connection Problem	2	2
Improper Chemical Reaction	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
Incomplete or Inadequate Connection	1	1
Failure to Deliver	1	1
Insufficient Device Problem Information	1	1
Failure to Cut	1	1
Difficult or Delayed Positioning	1	1
Packaging Problem	1	1
Poor Visibility	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	963	963
Pain	390	390
Discomfort	228	228
Abscess	181	181
Fistula	159	159
Hemorrhage/Blood Loss/Bleeding	150	150
Inflammation	150	150
Ulcer	135	135
Fluid Discharge	129	129
Unspecified Infection	123	123
Urinary Retention	106	106
Constipation	99	99
Fever	79	79
Perforation	71	71
Swelling/ Edema	52	52
Insufficient Information	52	52
No Consequences Or Impact To Patient	48	48
Hypersensitivity/Allergic reaction	43	43
Diarrhea	42	42
Urinary Frequency / Polyuria	34	34
Dysuria	33	33
Necrosis	25	25
Cramp(s) /Muscle Spasm(s)	23	23
Unspecified Kidney or Urinary Problem	22	22
Micturition Urgency	22	22
Syncope/Fainting	21	21
Loss of consciousness	20	20
Urinary Tract Infection	19	19
Hematoma	19	19
Erosion	18	18
Nausea	18	18
Embolism/Embolus	17	17
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	17	17
Low Blood Pressure/ Hypotension	17	17
Chills	17	17
Hematuria	17	17
Rash	16	16
Purulent Discharge	15	15
Obstruction/Occlusion	15	15
Burning Sensation	14	14
Unspecified Tissue Injury	14	14
Abdominal Pain	14	14
Vomiting	13	13
Fecal Incontinence	12	12
Skin Inflammation/ Irritation	12	12
Itching Sensation	12	12
Bacterial Infection	12	12
Cardiac Arrest	11	11
Sepsis	11	11
Urinary Incontinence	11	11

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