TPLC - Total Product Life Cycle

• Device: surgical film
• Definition: To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
• Product Code: OOD
• Regulation Number: 878.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
TEPHA, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	17	17
2020	72	72
2021	98	98
2022	430	430
2023	126	126
2024	69	69

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	366	366
Defective Device	329	329
Patient Device Interaction Problem	299	299
Insufficient Information	79	79
Device Appears to Trigger Rejection	21	21
Adverse Event Without Identified Device or Use Problem	18	18
Migration	12	12
Material Deformation	6	6
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Migration or Expulsion of Device	3	3
Expiration Date Error	2	2
Tear, Rip or Hole in Device Packaging	2	2
Improper or Incorrect Procedure or Method	2	2
Delivered as Unsterile Product	2	2
Material Split, Cut or Torn	2	2
No Apparent Adverse Event	2	2
Device Contamination with Chemical or Other Material	2	2
Expulsion	2	2
Off-Label Use	1	1
Thickening of Material	1	1
Deformation Due to Compressive Stress	1	1
Inadequate Instructions for Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	260	260
Pain	149	149
Seroma	70	70
Injury	69	69
Impaired Healing	63	63
Unspecified Infection	58	58
Wound Dehiscence	51	51
Necrosis	35	35
Hernia	32	32
Hematoma	30	30
Erythema	29	29
Disability	28	28
Bacterial Infection	26	26
Breast Discomfort/Pain	25	25
No Clinical Signs, Symptoms or Conditions	20	20
Fluid Discharge	18	18
Unspecified Reproductive System or Breast Problem	18	18
Capsular Contracture	18	18
Swelling/ Edema	15	15
Physical Asymmetry	14	14
Abdominal Pain	12	12
Cellulitis	10	10
Post Operative Wound Infection	9	9
Fistula	9	9
Abscess	7	7
Ptosis	7	7
Breast Cancer	6	6
Scar Tissue	5	5
Hypersensitivity/Allergic reaction	5	5
Erosion	5	5
Cancer	5	5
Rash	5	5
Purulent Discharge	5	5
Nerve Damage	4	4
Obstruction/Occlusion	4	4
Adhesion(s)	4	4
Unspecified Tissue Injury	4	4
Inflammation	4	4
Skin Disorders	3	3
Vomiting	3	3
Itching Sensation	3	3
Blister	2	2
Breast Mass	2	2
Urinary Tract Infection	2	2
Skin Inflammation/ Irritation	2	2
Neuralgia	2	2
Cyanosis	2	2
Nausea	2	2
Urinary Retention	2	2
Death	2	2
Reaction	2	2
Drug Resistant Bacterial Infection	2	2
Urticaria	2	2
Deformity/ Disfigurement	2	2
Sepsis	2	2
Ulcer	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscle/Tendon Damage	1	1
Contact Dermatitis	1	1
Failure of Implant	1	1
Burning Sensation	1	1
Pocket Erosion	1	1
Fibrosis	1	1
Implant Pain	1	1
Not Applicable	1	1
Gastrointestinal Hemorrhage	1	1
Bowel Perforation	1	1
Swelling	1	1
Raynauds Phenomenon	1	1
Loss of Range of Motion	1	1
Urinary Frequency	1	1
Fasciitis	1	1
Peritonitis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemorrhage/Bleeding	1	1
Micturition Urgency	1	1
Hypoxia	1	1
Patient Problem/Medical Problem	1	1
Diarrhea	1	1
Discomfort	1	1
Nodule	1	1
Autoimmune Reaction	1	1
Unspecified Gastrointestinal Problem	1	1