TPLC - Total Product Life Cycle

• Device: prosthesis, testicular
• Definition: Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
• Product Code: FAF
• Regulation Number: 876.3750
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	1	0	0	0	0	0	0	0	1	1	0	0	2	0	0

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	4	4
2016	8	8
2017	1	1
2018	6	6
2019	5	5
2020	8	8
2021	1	1
2022	1	1
2023	6	6
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	9	9
Fluid/Blood Leak	8	8
Leak/Splash	5	5
Positioning Problem	4	4
Insufficient Information	4	4
Device Markings/Labelling Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Break	2	2
Material Deformation	2	2
Inadequacy of Device Shape and/or Size	2	2
Appropriate Term/Code Not Available	2	2
Migration	2	2
Unintended Deflation	1	1
Device Handling Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Migration or Expulsion of Device	1	1
Material Puncture/Hole	1	1
Material Integrity Problem	1	1
Device Operates Differently Than Expected	1	1
Device Contamination with Chemical or Other Material	1	1
Material Erosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
No Information	9	9
No Known Impact Or Consequence To Patient	5	5
No Code Available	5	5
Failure of Implant	4	4
No Consequences Or Impact To Patient	3	3
Irritation	2	2
Wound Dehiscence	2	2
Unspecified Infection	2	2
Pain	2	2
Itching Sensation	1	1
Scarring	1	1
Cognitive Changes	1	1
Toxicity	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Adhesion(s)	1	1
Pocket Erosion	1	1
Reaction	1	1
Complaint, Ill-Defined	1	1
Hair Loss	1	1
Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Coloplast Manufacturing US, LLC	II	Dec-27-2010