TPLC - Total Product Life Cycle

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Device	surgical film
Regulation Description	Surgical mesh.
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
Patient-Device Incompatibility	566	568
Defective Device	368	369
Patient Device Interaction Problem	368	369
Adverse Event Without Identified Device or Use Problem	36	36
Device Appears to Trigger Rejection	23	23
Migration	22	22
Insufficient Device Problem Information	19	19
Material Deformation	13	13
Material Split, Cut or Torn	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Device Contamination with Chemical or Other Material	5	5
Migration or Expulsion of Device	4	4
Delivered as Unsterile Product	4	4
Tear, Rip or Hole in Device Packaging	4	4
Use of Device Problem	3	3
Expiration Date Error	2	2
Improper or Incorrect Procedure or Method	2	2
Material Integrity Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Material Rupture	1	1
No Apparent Adverse Event	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	352	354
Pain	176	177
Seroma	121	121
Unspecified Infection	85	87
Hernia	74	74
Impaired Healing	71	71
Wound Dehiscence	64	64
Necrosis	50	51
Hematoma	47	47
Capsular Contracture	41	42
Breast Discomfort/Pain	37	37
Erythema	34	34
No Clinical Signs, Symptoms or Conditions	33	33
Bacterial Infection	29	29
Physical Asymmetry	29	30
Adhesion(s)	26	26
Abscess	23	23
Abdominal Pain	20	20
Unspecified Reproductive System or Breast Problem	20	20
Cellulitis	18	18
Fluid Discharge	18	18
Swelling/ Edema	18	18
Ptosis	17	17
Injury	17	17
Fistula	14	14
Post Operative Wound Infection	14	14
Scar Tissue	13	14
Obstruction/Occlusion	12	12
Purulent Discharge	11	11
Disability	11	11
Breast Cancer	11	11
Inflammation	8	8
Sepsis	8	9
Hypersensitivity/Allergic reaction	7	7
Rash	6	6
Drug Resistant Bacterial Infection	6	6
Erosion	5	5
Cancer	5	5
Neuralgia	5	5
Unspecified Tissue Injury	4	4
Nerve Damage	4	4
Itching Sensation	3	3
Skin Inflammation/ Irritation	3	3
Discomfort	3	3
Vomiting	3	3
Deformity/ Disfigurement	2	2
Urinary Retention	2	2
Urinary Tract Infection	2	2
Burning Sensation	2	2
Fever	2	2