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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 3
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
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
2016 508 508
2017 529 529
2018 356 356
2019 417 417
2020 464 464
2021 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1140 1140
Appropriate Term/Code Not Available 604 604
Insufficient Information 322 322
Migration or Expulsion of Device 131 131
Patient Device Interaction Problem 69 69
Defective Device 38 38
Migration 37 37
Degraded 30 30
Material Erosion 30 30
Device Operates Differently Than Expected 29 29
Patient-Device Incompatibility 26 26
Material Split, Cut or Torn 25 25
Material Integrity Problem 21 21
Loss of or Failure to Bond 21 21
Material Perforation 13 13
Detachment of Device or Device Component 12 12
Material Deformation 10 10
Product Quality Problem 10 10
Microbial Contamination of Device 8 8
Break 8 8
Material Disintegration 8 8
Contamination 7 7
Device Appears to Trigger Rejection 6 6
Therapeutic or Diagnostic Output Failure 5 5
Device Contamination With Biological Material 5 5
Device Dislodged or Dislocated 4 4
Improper or Incorrect Procedure or Method 4 4
Split 4 4
Torn Material 4 4
No Apparent Adverse Event 4 4
Leak/Splash 4 4
Detachment Of Device Component 4 4
Device Expiration Issue 4 4
Fluid Leak 3 3
Entrapment of Device 3 3
Shelf Life Exceeded 3 3
Material Fragmentation 3 3
Hole In Material 3 3
Material Protrusion/Extrusion 3 3
Mechanics Altered 3 3
Biocompatibility 3 3
Fitting Problem 2 2
Delamination 2 2
Difficult to Open or Close 2 2
Device Contamination with Chemical or Other Material 2 2
Unintended Movement 2 2
Device Emits Odor 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Flaked 2 2
Failure To Adhere Or Bond 2 2
Air Leak 1 1
Calcified 1 1
Clumping in Device or Device Ingredient 1 1
Fracture 1 1
Disconnection 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Device Contamination with Body Fluid 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Separation 1 1
Peeled/Delaminated 1 1
Physical Resistance/Sticking 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Radiation Overexposure 1 1
Expulsion 1 1
Extrusion 1 1
Device Packaging Compromised 1 1
Failure to Form Staple 1 1
Contamination /Decontamination Problem 1 1
Malposition of Device 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 769 769
No Code Available 763 763
Pain 501 501
Unspecified Infection 400 400
Hernia 373 373
Adhesion(s) 312 312
Seroma 170 170
Erosion 136 136
Abscess 129 129
Not Applicable 107 107
Inflammation 101 101
Impaired Healing 101 101
Fistula 100 101
Obstruction/Occlusion 97 97
Abdominal Pain 94 95
Necrosis 87 87
Purulent Discharge 77 77
Failure of Implant 72 72
Wound Dehiscence 61 61
Discharge 59 59
Post Operative Wound Infection 55 55
Unspecified Tissue Injury 50 50
Hematoma 49 49
Abdominal Distention 48 48
Incontinence 46 46
No Consequences Or Impact To Patient 43 43
Scar Tissue 43 43
Nausea 42 42
Fever 41 41
Ascites 41 41
Blood Loss 39 39
Bacterial Infection 39 39
Scarring 39 39
Sepsis 38 38
Urinary Tract Infection 38 38
Discomfort 36 36
Vomiting 33 33
No Known Impact Or Consequence To Patient 33 33
Foreign Body Reaction 32 32
Fluid Discharge 30 30
Hemorrhage/Bleeding 26 26
Cellulitis 26 26
Erythema 25 25
Swelling 24 24
Fibrosis 23 23
Prolapse 19 19
Urinary Retention 19 19
Capsular Contracture 19 19
Death 18 18
Disability 18 18
No Information 17 17
Hypersensitivity/Allergic reaction 15 15
Constipation 14 14
Bowel Perforation 14 14
Ambulation Difficulties 13 13
Reaction 12 12
Abnormal Vaginal Discharge 12 12
Nerve Damage 12 12
Perforation 11 11
Diarrhea 11 11
Calcium Deposits/Calcification 11 11
Edema 10 10
Staphylococcus Aureus 10 10
Ulceration 10 10
Respiratory Failure 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Patient Problem/Medical Problem 9 9
Tachycardia 9 9
Complaint, Ill-Defined 9 9
Excessive Tear Production 9 9
Granuloma 9 9
Ischemia 9 9
Failure to Anastomose 9 9
Dysphagia/ Odynophagia 8 8
Necrosis Of Flap Tissue 8 8
Micturition Urgency 8 8
Fatigue 8 8
Burning Sensation 8 8
Cramp(s) 7 7
Peritonitis 7 7
Internal Organ Perforation 7 7
Pocket Erosion 7 7
No Patient Involvement 7 7
Fungal Infection 6 6
Insufficient Information 6 6
Renal Failure 6 6
Ulcer 6 6
Urinary Frequency 6 6
Irritation 6 6
Anemia 6 6
Anaphylactic Shock 5 5
Corneal Pannus 5 5
Low Blood Pressure/ Hypotension 5 5
Stenosis 5 5
Depression 5 5
Neurological Deficit/Dysfunction 5 5
Thrombosis 5 5
Hematuria 5 5
Skin Inflammation 5 5
Weight Changes 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
4 Baxter Healthcare Corporation II Jan-08-2021
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