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
Patient-Device Incompatibility	356	356
Defective Device	316	316
Patient Device Interaction Problem	286	286
Insufficient Information	79	79
Device Appears to Trigger Rejection	21	21
Adverse Event Without Identified Device or Use Problem	17	17
Migration	12	12
Material Deformation	5	5
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Migration or Expulsion of Device	3	3
Delivered as Unsterile Product	2	2
Improper or Incorrect Procedure or Method	2	2
Tear, Rip or Hole in Device Packaging	2	2
Expiration Date Error	2	2
No Apparent Adverse Event	2	2
Expulsion	2	2
Device Contamination with Chemical or Other Material	2	2
Material Split, Cut or Torn	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	246	246
Pain	148	148
Injury	69	69
Seroma	65	65
Impaired Healing	63	63
Unspecified Infection	54	54
Wound Dehiscence	49	49
Necrosis	35	35
Erythema	29	29
Hernia	29	29
Disability	28	28
Hematoma	28	28
Breast Discomfort/Pain	25	25
Bacterial Infection	24	24
No Clinical Signs, Symptoms or Conditions	19	19
Capsular Contracture	18	18
Unspecified Reproductive System or Breast Problem	18	18
Fluid Discharge	18	18
Swelling/ Edema	15	15
Physical Asymmetry	14	14
Abdominal Pain	12	12
Post Operative Wound Infection	9	9
Cellulitis	8	8
Abscess	7	7
Ptosis	7	7
Breast Cancer	6	6
Purulent Discharge	5	5
Erosion	5	5
Fistula	5	5
Hypersensitivity/Allergic reaction	5	5
Scar Tissue	5	5
Rash	5	5
Cancer	5	5
Unspecified Tissue Injury	4	4
Nerve Damage	4	4
Adhesion(s)	4	4
Inflammation	3	3
Itching Sensation	3	3
Skin Disorders	3	3
Obstruction/Occlusion	3	3
Vomiting	3	3
Deformity/ Disfigurement	2	2
Urticaria	2	2
Breast Mass	2	2
Reaction	2	2
Skin Inflammation/ Irritation	2	2
Blister	2	2
Nausea	2	2
Sepsis	2	2
Cyanosis	2	2
Death	2	2
Drug Resistant Bacterial Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Diarrhea	1	1
Autoimmune Reaction	1	1
Micturition Urgency	1	1
Hemorrhage/Bleeding	1	1
Swelling	1	1
Raynauds Phenomenon	1	1
Pocket Erosion	1	1
Loss of Range of Motion	1	1
Hypoxia	1	1
Failure of Implant	1	1
Implant Pain	1	1
Contact Dermatitis	1	1
Nodule	1	1
Neuralgia	1	1
Gastrointestinal Hemorrhage	1	1
Unspecified Gastrointestinal Problem	1	1
Muscle/Tendon Damage	1	1
Patient Problem/Medical Problem	1	1
Fibrosis	1	1
Not Applicable	1	1
Discomfort	1	1
Burning Sensation	1	1
Ulcer	1	1
Urinary Frequency	1	1