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	1256	1256
Adverse Event Without Identified Device or Use Problem	348	348
Migration	48	48
Material Integrity Problem	43	43
Obstruction of Flow	38	38
Defective Device	32	32
Malposition of Device	31	31
Device Contamination with Chemical or Other Material	21	21
Inadequacy of Device Shape and/or Size	16	16
Use of Device Problem	15	15
Appropriate Term/Code Not Available	13	13
Material Deformation	8	8
Patient Device Interaction Problem	7	7
Contamination	4	4
Activation, Positioning or Separation Problem	3	3
Unsealed Device Packaging	3	3
Device-Device Incompatibility	2	2
Device Ingredient or Reagent Problem	2	2
Break	2	2
Positioning Failure	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
Deflation Problem	1	1
Precipitate in Device or Device Ingredient	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	822	822
Pain	356	356
Discomfort	205	205
Abscess	153	153
Fistula	143	143
Inflammation	127	127
Hemorrhage/Bleeding	125	125
Fluid Discharge	124	124
Ulcer	115	115
Unspecified Infection	101	101
Urinary Retention	87	87
Constipation	83	83
Fever	66	66
Perforation	58	58
Insufficient Information	52	52
No Consequences Or Impact To Patient	48	48
Swelling/ Edema	46	46
Hypersensitivity/Allergic reaction	39	39
Diarrhea	37	37
Urinary Frequency	29	29
Dysuria	27	27
Unspecified Kidney or Urinary Problem	21	21
Cramp(s) /Muscle Spasm(s)	21	21
Necrosis	20	20
Micturition Urgency	18	18
Embolism/Embolus	17	17
Urinary Tract Infection	17	17
Erosion	16	16
Loss of consciousness	16	16
Syncope/Fainting	16	16
Obstruction/Occlusion	15	15
Hematuria	15	15
Hematoma	15	15
Chills	14	14
Nausea	13	13
Low Blood Pressure/ Hypotension	13	13
Burning Sensation	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Rash	13	13
Skin Inflammation/ Irritation	12	12
Cardiac Arrest	11	11
Purulent Discharge	11	11
Unspecified Tissue Injury	11	11
Abdominal Pain	11	11
Fecal Incontinence	10	10
Bacterial Infection	10	10
Vomiting	10	10
Sepsis	10	10
Dizziness	9	9
Itching Sensation	9	9

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