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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 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 394 394
Patient-Device Incompatibility 388 388
Patient Device Interaction Problem 364 364
Insufficient Information 79 79
Device Appears to Trigger Rejection 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Migration 12 12
Material Deformation 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Migration or Expulsion of Device 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
Delivered as Unsterile Product 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 327 327
Pain 154 154
Seroma 74 74
Injury 69 69
Unspecified Infection 66 66
Impaired Healing 63 63
Wound Dehiscence 54 54
Necrosis 37 37
Hernia 34 34
Hematoma 30 30
Erythema 29 29
Disability 28 28
Bacterial Infection 27 27
Breast Discomfort/Pain 26 26
No Clinical Signs, Symptoms or Conditions 22 22
Capsular Contracture 19 19
Unspecified Reproductive System or Breast Problem 18 18
Physical Asymmetry 18 18
Fluid Discharge 18 18
Swelling/ Edema 15 15
Abdominal Pain 13 13
Fistula 10 10
Ptosis 10 10
Cellulitis 10 10
Post Operative Wound Infection 9 9
Abscess 7 7
Breast Cancer 6 6
Scar Tissue 6 6
Cancer 5 5
Erosion 5 5
Rash 5 5
Purulent Discharge 5 5
Inflammation 5 5
Hypersensitivity/Allergic reaction 5 5
Obstruction/Occlusion 4 4
Adhesion(s) 4 4
Nerve Damage 4 4
Unspecified Tissue Injury 4 4
Skin Disorders 3 3
Itching Sensation 3 3
Vomiting 3 3
Sepsis 3 3
Cyanosis 2 2
Urticaria 2 2
Urinary Tract Infection 2 2
Neuralgia 2 2
Deformity/ Disfigurement 2 2
Death 2 2
Breast Mass 2 2
Drug Resistant Bacterial Infection 2 2

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