TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	394	394
Patient-Device Incompatibility	388	388
Patient Device Interaction Problem	364	364
Insufficient Information	79	79
Device Appears to Trigger Rejection	21	21
Adverse Event Without Identified Device or Use Problem	19	19
Migration	12	12
Material Deformation	6	6
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Device Contamination with Chemical or Other Material	3	3
Tear, Rip or Hole in Device Packaging	3	3
Migration or Expulsion of Device	3	3
Material Split, Cut or Torn	2	2
Expulsion	2	2
Expiration Date Error	2	2
Delivered as Unsterile Product	2	2
No Apparent Adverse Event	2	2
Improper or Incorrect Procedure or Method	2	2
Thickening of Material	1	1
Deformation Due to Compressive Stress	1	1
Off-Label Use	1	1
Inadequate Instructions for Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	327	327
Pain	154	154
Seroma	74	74
Injury	69	69
Unspecified Infection	66	66
Impaired Healing	63	63
Wound Dehiscence	54	54
Necrosis	37	37
Hernia	34	34
Hematoma	30	30
Erythema	29	29
Disability	28	28
Bacterial Infection	27	27
Breast Discomfort/Pain	26	26
No Clinical Signs, Symptoms or Conditions	22	22
Capsular Contracture	19	19
Unspecified Reproductive System or Breast Problem	18	18
Physical Asymmetry	18	18
Fluid Discharge	18	18
Swelling/ Edema	15	15
Abdominal Pain	13	13
Fistula	10	10
Ptosis	10	10
Cellulitis	10	10
Post Operative Wound Infection	9	9
Abscess	7	7
Breast Cancer	6	6
Scar Tissue	6	6
Cancer	5	5
Erosion	5	5
Rash	5	5
Purulent Discharge	5	5
Inflammation	5	5
Hypersensitivity/Allergic reaction	5	5
Obstruction/Occlusion	4	4
Adhesion(s)	4	4
Nerve Damage	4	4
Unspecified Tissue Injury	4	4
Skin Disorders	3	3
Itching Sensation	3	3
Vomiting	3	3
Sepsis	3	3
Cyanosis	2	2
Urticaria	2	2
Urinary Tract Infection	2	2
Neuralgia	2	2
Deformity/ Disfigurement	2	2
Death	2	2
Breast Mass	2	2
Drug Resistant Bacterial Infection	2	2