TPLC - Total Product Life Cycle

show TPLC since

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	495	497
Defective Device	371	372
Patient Device Interaction Problem	369	370
Adverse Event Without Identified Device or Use Problem	33	33
Device Appears to Trigger Rejection	22	22
Insufficient Information	21	21
Migration	17	17
Material Deformation	12	12
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Delivered as Unsterile Product	4	4
Tear, Rip or Hole in Device Packaging	4	4
Device Contamination with Chemical or Other Material	4	4
Migration or Expulsion of Device	3	3
Material Split, Cut or Torn	2	2
Expiration Date Error	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	1	2
Inadequate Instructions for Healthcare Professional	1	1
Use of Device Problem	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	347	349
Pain	159	160
Seroma	104	104
Unspecified Infection	78	80
Impaired Healing	70	70
Wound Dehiscence	61	61
Hernia	59	59
Necrosis	48	49
Hematoma	44	44
Breast Discomfort/Pain	36	36
Erythema	33	33
No Clinical Signs, Symptoms or Conditions	27	27
Capsular Contracture	25	26
Bacterial Infection	24	24
Physical Asymmetry	24	25
Abscess	23	23
Adhesion(s)	21	21
Unspecified Reproductive System or Breast Problem	19	19
Fluid Discharge	18	18
Injury	17	17
Abdominal Pain	16	16
Swelling/ Edema	15	15
Cellulitis	15	15
Ptosis	15	15
Post Operative Wound Infection	14	14
Fistula	14	14
Scar Tissue	13	14
Disability	11	11
Purulent Discharge	11	11
Breast Cancer	11	11
Obstruction/Occlusion	9	9
Inflammation	8	8
Sepsis	8	9
Hypersensitivity/Allergic reaction	7	7
Erosion	5	5
Cancer	5	5
Drug Resistant Bacterial Infection	5	5
Unspecified Tissue Injury	4	4
Neuralgia	4	4
Rash	4	4
Nerve Damage	4	4
Itching Sensation	3	3
Vomiting	3	3
Deformity/ Disfigurement	2	2
Discomfort	2	2
Urinary Tract Infection	2	2
Urinary Retention	2	2
Burning Sensation	2	2
Skin Disorders	2	2
Blister	2	2