TPLC - Total Product Life Cycle

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Device	prosthesis, penis, inflatable
Regulation Description	Penile inflatable implant.
Definition	PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product Code	JCW
Regulation Number	876.3350
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
5	5	7	4	5	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	925	926
Inflation Problem	683	683
Material Puncture/Hole	660	660
Adverse Event Without Identified Device or Use Problem	629	629
Fluid/Blood Leak	545	545
Migration	301	302
Nonstandard Device	224	224
Deflation Problem	122	122
Collapse	108	108
Defective Device	104	104
Inadequacy of Device Shape and/or Size	96	97
Air/Gas in Device	85	85
Malposition of Device	79	79
Degraded	66	66
Insufficient Device Problem Information	60	60
Unintended Deflation	46	46
Material Deformation	41	41
Failure to Deflate	38	38
Connection Problem	23	23
Human-Device Interface Problem	10	10
Device Contamination with Chemical or Other Material	9	9
Use of Device Problem	9	9
Fracture	9	9
Break	5	5
Pumping Problem	5	5
Patient-Device Incompatibility	3	3
Difficult or Delayed Activation	2	2
Material Discolored	2	2
Device Contaminated During Manufacture or Shipping	2	2
Component Missing	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination	1	1
Material Protrusion/Extrusion	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Off-Label Use	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1799	1799
Pain	263	263
Unspecified Infection	257	257
Erosion	144	144
Discomfort	144	144
Swelling/ Edema	77	77
Unspecified Tissue Injury	62	63
Deformity/ Disfigurement	41	41
Scar Tissue	31	31
Wound Dehiscence	30	30
Purulent Discharge	30	30
Perforation	28	28
Insufficient Information	26	26
Capsular Contracture	25	25
Adhesion(s)	22	22
Hematoma	21	21
Inflammation	20	20
Erythema	16	16
Hernia	15	15
Failure of Implant	11	11
Fluid Discharge	11	11
Fever	11	11
Urinary Retention	10	10
Skin Inflammation/ Irritation	9	9
Bacterial Infection	9	9
Numbness	8	8
Bruise/Contusion	6	6
Abscess	6	6
Anxiety	5	5
Dysuria	5	5
Fibrosis	5	5
Hematuria	5	5
Obstruction/Occlusion	5	5
No Known Impact Or Consequence To Patient	4	4
Depression	4	4
Urinary Tract Infection	4	4
Necrosis	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Urinary Incontinence	3	3
Nerve Damage	3	3
Post Operative Wound Infection	3	3
Skin Erosion	2	2
Implant Pain	2	2
Muscle Weakness/Atrophy	2	2
Abdominal Pain	2	2
Impaired Healing	2	2
Localized Skin Lesion	2	2
Sepsis	2	2
Incontinence	2	2
Ulcer	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Oct-10-2025
2	Boston Scientific Corporation	II	Apr-16-2021