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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical
Regulation Description Surgical mesh.
Product CodeFTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACELL, INC
  SUBSTANTIALLY EQUIVALENT 1
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLORADO THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
CURASEAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 2
MIROMATRIX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENIX GROUP PLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 977 977
2016 508 508
2017 530 530
2018 358 358
2019 417 417
2020 403 403

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1227 1227
Insufficient Information 651 651
Appropriate Term/Code Not Available 634 634
Migration or Expulsion of Device 237 237
Other (for use when an appropriate device code cannot be identified) 189 189
Device Operates Differently Than Expected 72 72
Patient Device Interaction Problem 60 60
Material Erosion 44 44
Patient-Device Incompatibility 34 34
Degraded 30 30
Migration 29 29
Defective Device 28 28
Loss of or Failure to Bond 21 21
Material Integrity Problem 20 20
Material Split, Cut or Torn 17 17
Break 13 13
Material Disintegration 13 13
Material Perforation 13 13
Material Deformation 13 13
Product Quality Problem 11 11
Microbial Contamination of Device 11 11
Split 10 10
Torn Material 10 10
Leak/Splash 10 10
Contamination 9 9
Entrapment of Device 9 9
Material Rupture 9 9
Therapeutic or Diagnostic Output Failure 7 7
Detachment of Device or Device Component 7 7
Fluid Leak 7 7
Hole In Material 6 6
Improper or Incorrect Procedure or Method 6 6
Device Appears to Trigger Rejection 5 5
Device Contamination With Biological Material 5 5
Extrusion 5 5
Difficult to Remove 5 5
Device Dislodged or Dislocated 5 5
Material Protrusion/Extrusion 4 4
Device Expiration Issue 4 4
Detachment Of Device Component 4 4
Failure To Adhere Or Bond 3 3
Device Contamination with Chemical or Other Material 3 3
Malposition of Device 3 3
Biocompatibility 3 3
Mechanics Altered 3 3
Device Emits Odor 3 3
Material Fragmentation 3 3
Shelf Life Exceeded 3 3
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Difficult to Open or Close 2 2
Noise, Audible 2 2
Material Separation 2 2
Failure to Form Staple 2 2
Delamination 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Matrices 2 2
Flaked 2 2
Fitting Problem 2 2
Unintended Movement 2 2
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Misfire 1 1
Peeled/Delaminated 1 1
Material Discolored 1 1
Disconnection 1 1
Clumping in Device or Device Ingredient 1 1
Component Falling 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Radiation Overexposure 1 1
Contamination /Decontamination Problem 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Ring 1 1
Air Leak 1 1
Calcified 1 1
Explanted 1 1
Material Too Rigid or Stiff 1 1
Cord 1 1
Fracture 1 1
Folded 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Tears, rips, holes in device, device material 1 1
Failure to Unfold or Unwrap 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 914 914
No Code Available 911 911
Pain 884 884
Unspecified Infection 408 408
Hernia 349 349
Adhesion(s) 290 290
Erosion 262 262
Inflammation 180 180
Other (for use when an appropriate patient code cannot be identified) 180 180
Seroma 168 168
Abscess 123 123
Incontinence 113 113
Not Applicable 110 110
Impaired Healing 107 107
Obstruction/Occlusion 99 99
Abdominal Pain 92 93
Fistula 88 89
Necrosis 81 81
Wound Dehiscence 75 75
Failure of Implant 72 72
Purulent Discharge 70 70
Discharge 60 60
Fever 57 57
Post Operative Wound Infection 56 56
Reaction 54 54
Hematoma 50 50
Blood Loss 46 46
Abdominal Distention 45 45
No Consequences Or Impact To Patient 45 45
Nausea 44 44
Bacterial Infection 43 43
No Known Impact Or Consequence To Patient 42 42
Erythema 41 41
Scarring 41 41
Urinary Tract Infection 41 41
Hypersensitivity/Allergic reaction 40 40
Vomiting 39 39
Ascites 39 39
Sepsis 38 38
Discomfort 36 36
Scar Tissue 33 33
Foreign Body Reaction 29 29
Hemorrhage/Bleeding 28 28
Edema 27 27
Swelling 26 26
Complaint, Ill-Defined 26 26
Urinary Retention 26 26
Fluid Discharge 25 25
Cellulitis 24 24
Prolapse 23 23
Death 22 22
Capsular Contracture 21 21
Failure to Anastomose 21 21
Fibrosis 21 21
No Information 18 18
Constipation 17 17
Disability 16 16
Bowel Perforation 15 15
Staphylococcus Aureus 15 15
Abnormal Vaginal Discharge 14 14
Ambulation Difficulties 14 14
Perforation 13 13
Nerve Damage 12 12
Ischemia 12 12
Diarrhea 11 11
Calcium Deposits/Calcification 11 11
Tachycardia 10 10
Ulceration 10 10
Tissue Damage 10 10
Therapeutic Response, Decreased 10 10
Respiratory Failure 10 10
Malaise 9 9
Stenosis 9 9
Patient Problem/Medical Problem 9 9
Excessive Tear Production 9 9
Unknown (for use when the patient's condition is not known) 9 9
Burning Sensation 9 9
Necrosis Of Flap Tissue 9 9
Dysphagia/ Odynophagia 9 9
Endocarditis 9 9
Fatigue 9 9
Granuloma 9 9
Micturition Urgency 8 8
Internal Organ Perforation 8 8
Pocket Erosion 7 7
Cramp(s) 7 7
Peritonitis 7 7
Fungal Infection 7 7
No Patient Involvement 7 7
Surgical procedure 7 7
Weight Changes 6 6
Hematuria 6 6
Ulcer 6 6
Urinary Frequency 6 6
Renal Failure 6 6
Irritation 6 6
Headache 6 6
Low Blood Pressure/ Hypotension 6 6
Anemia 6 6
Anaphylactic Shock 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Mar-21-2019
2 AROA Biosurgery, LTD. II Nov-09-2018
3 AZIYO BIOLOGICS II Oct-04-2019
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