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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device mesh, surgical, polymeric
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ARISTE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXOGENESIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 4
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 21721 21721
2020 18816 18816
2021 16284 16284
2022 11439 11439
2023 8025 8025
2024 2303 2303

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 47373 47373
Insufficient Information 26734 26734
Adverse Event Without Identified Device or Use Problem 25111 25111
Patient Device Interaction Problem 24664 24664
Mechanics Altered 3847 3847
Migration or Expulsion of Device 3489 3489
Patient-Device Incompatibility 1301 1301
Material Deformation 783 783
Appropriate Term/Code Not Available 759 759
Material Split, Cut or Torn 743 743
Material Integrity Problem 522 522
Loss of or Failure to Bond 390 390
Migration 365 365
Material Erosion 298 298
Degraded 290 290
Detachment of Device or Device Component 200 200
Therapeutic or Diagnostic Output Failure 91 91
Material Perforation 88 88
Material Separation 74 74
Material Protrusion/Extrusion 64 64
Break 60 60
Expiration Date Error 58 58
Product Quality Problem 55 55
Delivered as Unsterile Product 48 48
No Apparent Adverse Event 42 42
Device Markings/Labelling Problem 41 41
Use of Device Problem 38 38
Microbial Contamination of Device 33 33
Device Contamination with Chemical or Other Material 33 33
Material Twisted/Bent 31 31
Improper or Incorrect Procedure or Method 31 31
Packaging Problem 28 28
Output Problem 22 22
Material Disintegration 22 22
Contamination 21 21
Device Appears to Trigger Rejection 18 18
Tear, Rip or Hole in Device Packaging 17 17
Unexpected Therapeutic Results 16 16
Material Frayed 16 16
Device Dislodged or Dislocated 16 16
Unsealed Device Packaging 15 15
Structural Problem 15 15
Off-Label Use 13 13
Entrapment of Device 13 13
Peeled/Delaminated 12 12
Failure to Osseointegrate 11 11
Difficult to Insert 9 9
Human-Device Interface Problem 9 9
Material Puncture/Hole 8 8
Difficult to Remove 8 8
Material Fragmentation 8 8
Nonstandard Device 7 7
Loose or Intermittent Connection 7 7
Defective Component 7 7
Contamination /Decontamination Problem 7 7
Physical Resistance/Sticking 7 7
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Difficult to Open or Close 6 6
Device Contaminated During Manufacture or Shipping 6 6
Deformation Due to Compressive Stress 6 6
Unraveled Material 6 6
Retraction Problem 5 5
Obstruction of Flow 5 5
Unintended Movement 5 5
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 3 3
Material Too Rigid or Stiff 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device Damaged by Another Device 3 3
Biocompatibility 3 3
Difficult or Delayed Positioning 3 3
Device Difficult to Maintain 3 3
Expulsion 3 3
Difficult to Open or Remove Packaging Material 2 2
Positioning Problem 2 2
Protective Measures Problem 2 2
Component Misassembled 2 2
Lack of Effect 2 2
Disconnection 2 2
Fluid/Blood Leak 2 2
Mechanical Problem 2 2
Inadequate Instructions for Healthcare Professional 2 2
Malposition of Device 2 2
Component Missing 2 2
Device Damaged Prior to Use 2 2
Material Rupture 1 1
Stretched 1 1
Unstable 1 1
Failure to Unfold or Unwrap 1 1
Low Readings 1 1
Failure to Align 1 1
Failure to Form Staple 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1
Material Invagination 1 1
Leak/Splash 1 1
Melted 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fracture 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 38100 38104
Injury 32847 32847
Insufficient Information 22759 22759
Hernia 16284 16287
Adhesion(s) 14390 14395
Disability 12820 12820
Unspecified Tissue Injury 9997 9997
Unspecified Infection 7728 7731
Inflammation 7391 7393
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4312 4312
Scar Tissue 4259 4259
Emotional Changes 4012 4013
Obstruction/Occlusion 3475 3475
Abdominal Pain 3358 3359
Discomfort 3159 3159
Abscess 2941 2943
Nausea 2621 2621
No Code Available 2527 2528
Seroma 2492 2494
Not Applicable 1604 1604
Fistula 1592 1594
No Clinical Signs, Symptoms or Conditions 1543 1543
Erosion 1535 1537
Distress 1491 1491
Abdominal Distention 1257 1257
Diarrhea 1247 1247
Impaired Healing 1235 1237
Fluid Discharge 1196 1196
Purulent Discharge 1126 1126
Scarring 1121 1122
Decreased Appetite 1103 1103
Chills 1075 1075
Failure of Implant 1069 1070
Hematoma 1054 1054
Foreign Body Reaction 1040 1042
Nerve Damage 973 974
Swelling/ Edema 930 930
Weight Changes 892 892
Necrosis 845 845
Hemorrhage/Bleeding 824 824
Ascites 772 772
Fibrosis 712 712
Vomiting 656 656
Deformity/ Disfigurement 567 567
Bacterial Infection 550 550
Discharge 532 532
Perforation 528 528
No Information 486 486
Fever 432 432
Swelling 410 410
Muscle Weakness 406 406
Constipation 399 399
Wound Dehiscence 378 378
Nodule 365 365
Erythema 357 357
Cellulitis 330 330
Blood Loss 293 293
Granuloma 282 283
No Consequences Or Impact To Patient 264 264
Sepsis 247 247
Urinary Tract Infection 236 236
Incontinence 233 233
Depression 215 215
Urinary Retention 212 212
Bowel Perforation 209 209
Hypersensitivity/Allergic reaction 204 205
Numbness 201 201
Post Operative Wound Infection 196 197
Anxiety 183 183
Burning Sensation 171 171
Prolapse 168 168
Ischemia 167 167
Cramp(s) /Muscle Spasm(s) 154 154
Cyst(s) 142 142
Death 137 137
Ulcer 131 131
Sexual Dysfunction 127 127
Ambulation Difficulties 125 125
Foreign Body In Patient 121 121
Internal Organ Perforation 119 119
Fatigue 118 118
Edema 113 113
Skin Inflammation/ Irritation 108 108
Staphylococcus Aureus 107 107
Sleep Dysfunction 102 102
Tachycardia 101 101
Pneumonia 95 95
Rash 94 94
Urinary Frequency 92 92
Dysuria 91 91
Micturition Urgency 83 83
Thrombosis/Thrombus 80 80
Peritonitis 73 73
Hematuria 73 73
Weakness 72 72
Low Blood Pressure/ Hypotension 72 72
Anemia 71 71
Itching Sensation 70 70
Electrolyte Imbalance 68 68
Reaction 65 66

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Feb-22-2021
2 Covidien, LP II Feb-27-2023
3 Davol, Inc. II Jul-27-2023
4 Ethicon, Inc. II Dec-03-2020
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