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U.S. Department of Health and Human Services

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 CodeOOD
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 72 72
2021 98 98
2022 430 430
2023 127 127
2024 196 196
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 418 418
Defective Device 405 405
Patient Device Interaction Problem 373 373
Insufficient Information 74 74
Device Appears to Trigger Rejection 21 21
Adverse Event Without Identified Device or Use Problem 18 18
Migration 13 13
Material Deformation 9 9
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
Material Split, Cut or Torn 2 2
Expulsion 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Expiration Date Error 2 2
Thickening of Material 1 1
Off-Label Use 1 1
Deformation Due to Compressive Stress 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 339 339
Pain 158 158
Seroma 84 84
Unspecified Infection 71 71
Impaired Healing 65 65
Injury 64 64
Wound Dehiscence 60 60
Necrosis 40 40
Hematoma 36 36
Hernia 34 34
Breast Discomfort/Pain 32 32
Bacterial Infection 30 30
Erythema 29 29
Disability 28 28
Capsular Contracture 24 24
No Clinical Signs, Symptoms or Conditions 23 23
Physical Asymmetry 19 19
Fluid Discharge 18 18
Unspecified Reproductive System or Breast Problem 18 18
Swelling/ Edema 15 15
Abdominal Pain 14 14
Ptosis 12 12
Fistula 11 11
Cellulitis 11 11
Abscess 10 10
Post Operative Wound Infection 9 9
Scar Tissue 9 9
Breast Cancer 6 6
Purulent Discharge 6 6
Hypersensitivity/Allergic reaction 5 5
Cancer 5 5
Erosion 5 5
Adhesion(s) 5 5
Inflammation 5 5
Sepsis 4 4
Unspecified Tissue Injury 4 4
Drug Resistant Bacterial Infection 4 4
Obstruction/Occlusion 4 4
Nerve Damage 4 4
Skin Disorders 3 3
Itching Sensation 3 3
Vomiting 3 3
Neuralgia 2 2
Rash 2 2
Nausea 2 2
Blister 2 2
Cyanosis 2 2
Deformity/ Disfigurement 2 2
Breast Mass 2 2
Urticaria 2 2

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