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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	4179	4180
Mechanical Problem	3664	3696
Adverse Event Without Identified Device or Use Problem	3548	3570
Inflation Problem	3229	3230
Material Puncture/Hole	2574	2575
Fracture	1601	1601
Migration	1097	1121
Insufficient Information	948	954
Inadequacy of Device Shape and/or Size	881	881
Malposition of Device	601	601
Deflation Problem	576	576
Collapse	531	531
Defective Device	425	425
Pumping Problem	405	405
Degraded	312	312
Appropriate Term/Code Not Available	208	208
Material Deformation	193	193
Air/Gas in Device	147	147
Break	132	132
Physical Resistance/Sticking	123	123
Failure to Pump	105	105
Failure to Deflate	99	99
Device Appears to Trigger Rejection	90	90
Unintended Deflation	88	88
Self-Activation or Keying	77	77
Material Split, Cut or Torn	72	72
Material Frayed	69	69
Migration or Expulsion of Device	56	56
Connection Problem	56	56
Material Erosion	55	55
Positioning Problem	43	43
Difficult or Delayed Activation	40	40
Material Twisted/Bent	37	37
Material Protrusion/Extrusion	35	35
Nonstandard Device	33	33
Crack	33	33
Disconnection	28	28
No Apparent Adverse Event	27	27
Device Damaged by Another Device	27	27
Material Rupture	26	26
Use of Device Problem	25	26
Device Contamination with Chemical or Other Material	23	23
Patient-Device Incompatibility	22	22
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
Patient Device Interaction Problem	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13029	13069
Unspecified Infection	1547	1565
Erosion	890	890
Pain	834	835
Insufficient Information	481	481
Discomfort	476	476
Perforation	259	259
Bacterial Infection	195	195
Swelling/ Edema	176	176
No Consequences Or Impact To Patient	101	101
Scar Tissue	98	98
No Known Impact Or Consequence To Patient	97	97
Failure of Implant	90	90
Unspecified Tissue Injury	90	90
Hematoma	89	89
Adhesion(s)	84	84
Wound Dehiscence	83	83
Deformity/ Disfigurement	80	80
Purulent Discharge	76	76
Inflammation	67	67
Capsular Contracture	66	66
Hernia	62	62
Skin Erosion	62	62
Fibrosis	34	34
Hemorrhage/Bleeding	31	31
Fluid Discharge	26	26
Urinary Retention	21	21
Abscess	20	20
Impaired Healing	20	20
Depression	20	20
Dysuria	20	20
Anxiety	20	21
Numbness	19	19
Fever	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Erectile Dysfunction	17	17
Fistula	16	16
Burning Sensation	16	16
Urinary Incontinence	16	16
Sexual Dysfunction	16	16
Abdominal Pain	15	15
Hypersensitivity/Allergic reaction	14	14
Post Operative Wound Infection	14	30
Urinary Tract Infection	13	13
Skin Inflammation/ Irritation	12	12
Unspecified Mental, Emotional or Behavioural Problem	12	12
Unspecified Kidney or Urinary Problem	11	11
Distress	11	11
Aneurysm	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