TPLC - Total Product Life Cycle

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Device	device, impotence, mechanical/hydraulic
Regulation Description	Penile inflatable implant.
Definition	PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product Code	FHW
Regulation Number	876.3350
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
2	3	3	3	2	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	4258	4259
Mechanical Problem	3692	3724
Adverse Event Without Identified Device or Use Problem	3607	3629
Inflation Problem	3287	3288
Material Puncture/Hole	2604	2605
Fracture	1689	1689
Migration	1112	1136
Insufficient Information	997	1003
Inadequacy of Device Shape and/or Size	910	910
Malposition of Device	619	619
Deflation Problem	588	588
Collapse	533	533
Defective Device	425	425
Pumping Problem	414	414
Degraded	316	316
Appropriate Term/Code Not Available	208	208
Material Deformation	199	199
Air/Gas in Device	150	150
Break	133	133
Physical Resistance/Sticking	130	130
Failure to Pump	107	107
Failure to Deflate	103	103
Device Appears to Trigger Rejection	95	95
Unintended Deflation	94	94
Self-Activation or Keying	81	81
Material Split, Cut or Torn	72	72
Material Frayed	71	71
Connection Problem	58	58
Migration or Expulsion of Device	56	56
Material Erosion	55	55
Nonstandard Device	43	43
Positioning Problem	43	43
Difficult or Delayed Activation	40	40
Material Twisted/Bent	38	38
Crack	35	35
Material Protrusion/Extrusion	35	35
Device Damaged by Another Device	30	30
Disconnection	30	30
Material Rupture	28	28
No Apparent Adverse Event	27	27
Patient-Device Incompatibility	25	25
Use of Device Problem	25	26
Device Contamination with Chemical or Other Material	23	23
Leak/Splash	19	19
Material Discolored	19	19
Device Dislodged or Dislocated	16	16
Noise, Audible	16	16
Device Contaminated During Manufacture or Shipping	16	16
Deformation Due to Compressive Stress	14	14
Filling Problem	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13373	13413
Unspecified Infection	1577	1595
Erosion	919	919
Pain	841	842
Discomfort	482	482
Insufficient Information	482	482
Perforation	269	269
Bacterial Infection	196	196
Swelling/ Edema	175	175
No Consequences Or Impact To Patient	101	101
Scar Tissue	100	100
No Known Impact Or Consequence To Patient	96	96
Unspecified Tissue Injury	94	94
Hematoma	92	92
Failure of Implant	90	90
Adhesion(s)	85	85
Wound Dehiscence	84	84
Deformity/ Disfigurement	81	81
Purulent Discharge	78	78
Capsular Contracture	67	67
Inflammation	67	67
Hernia	62	62
Skin Erosion	62	62
Fibrosis	34	34
Hemorrhage/Bleeding	32	32
Fluid Discharge	26	26
Abscess	21	21
Urinary Retention	21	21
Anxiety	20	21
Dysuria	20	20
Impaired Healing	20	20
Depression	20	20
Fever	20	20
Numbness	19	19
Urinary Incontinence	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Erectile Dysfunction	17	17
Sexual Dysfunction	16	16
Fistula	16	16
Burning Sensation	16	16
Urinary Tract Infection	15	15
Abdominal Pain	15	15
Hypersensitivity/Allergic reaction	14	14
Post Operative Wound Infection	14	30
Skin Inflammation/ Irritation	12	12
Unspecified Mental, Emotional or Behavioural Problem	12	12
Distress	11	11
Aneurysm	11	11
Unspecified Kidney or Urinary Problem	11	11
Erythema	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Coloplast Manufacturing US, LLC	II	Apr-12-2023
2	Coloplast Manufacturing US, LLC	II	Dec-22-2021