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U.S. Department of Health and Human Services

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 CodeOOD
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 17 17
2020 72 72
2021 98 98
2022 430 430
2023 127 127
2024 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 402 402
Defective Device 398 398
Patient Device Interaction Problem 368 368
Insufficient Information 79 79
Device Appears to Trigger Rejection 22 22
Adverse Event Without Identified Device or Use Problem 19 19
Migration 13 13
Material Deformation 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Migration or Expulsion of Device 3 3
Delivered as Unsterile Product 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Contamination with Chemical or Other Material 3 3
Expulsion 2 2
Material Split, Cut or Torn 2 2
Expiration Date Error 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 1 1
Inadequate Instructions for Healthcare Professional 1 1
Thickening of Material 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 330 330
Pain 154 154
Seroma 79 79
Unspecified Infection 72 72
Injury 69 69
Impaired Healing 66 66
Wound Dehiscence 58 58
Necrosis 40 40
Hernia 35 35
Hematoma 34 34
Erythema 29 29
Bacterial Infection 29 29
Disability 28 28
Breast Discomfort/Pain 26 26
Capsular Contracture 24 24
No Clinical Signs, Symptoms or Conditions 23 23
Physical Asymmetry 19 19
Unspecified Reproductive System or Breast Problem 18 18
Fluid Discharge 18 18
Swelling/ Edema 15 15
Abdominal Pain 13 13
Cellulitis 11 11
Ptosis 11 11
Fistula 10 10
Post Operative Wound Infection 9 9
Abscess 8 8
Scar Tissue 8 8
Breast Cancer 6 6
Purulent Discharge 5 5
Erosion 5 5
Adhesion(s) 5 5
Rash 5 5
Hypersensitivity/Allergic reaction 5 5
Inflammation 5 5
Cancer 5 5
Obstruction/Occlusion 4 4
Nerve Damage 4 4
Unspecified Tissue Injury 4 4
Skin Disorders 3 3
Itching Sensation 3 3
Sepsis 3 3
Vomiting 3 3
Urinary Retention 2 2
Urinary Tract Infection 2 2
Reaction 2 2
Deformity/ Disfigurement 2 2
Urticaria 2 2
Breast Mass 2 2
Bowel Perforation 2 2
Neuralgia 2 2

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