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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, polymeric
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ARISTE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CR BARD INC.
  SUBSTANTIALLY EQUIVALENT 1
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXOGENESIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
LNTEGRA LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 5
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 11885 11885
2019 21721 21721
2020 18816 18816
2021 16284 16284
2022 11439 11439
2023 5302 5302

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 48435 48435
Insufficient Information 31609 31609
Adverse Event Without Identified Device or Use Problem 28623 28623
Patient Device Interaction Problem 21484 21484
Migration or Expulsion of Device 4193 4193
Mechanics Altered 3961 3961
Appropriate Term/Code Not Available 2109 2109
Patient-Device Incompatibility 1559 1559
Material Deformation 994 994
Material Split, Cut or Torn 786 786
Material Integrity Problem 603 603
Loss of or Failure to Bond 508 508
Material Erosion 417 417
Migration 392 392
Degraded 337 337
Detachment of Device or Device Component 278 278
Material Perforation 134 134
No Apparent Adverse Event 124 124
Material Separation 102 102
Break 96 96
Therapeutic or Diagnostic Output Failure 92 92
Material Protrusion/Extrusion 89 89
Product Quality Problem 76 76
Use of Device Problem 64 64
Microbial Contamination of Device 58 58
Expiration Date Error 55 55
Contamination 50 50
Device Markings/Labelling Problem 49 49
Device Operates Differently Than Expected 45 45
Delivered as Unsterile Product 38 38
Improper or Incorrect Procedure or Method 38 38
Material Twisted/Bent 35 35
Device Contamination with Chemical or Other Material 31 31
Packaging Problem 31 31
Tear, Rip or Hole in Device Packaging 29 29
Material Disintegration 26 26
Torn Material 24 24
Output Problem 23 23
Device Dislodged or Dislocated 23 23
Defective Component 21 21
Entrapment of Device 21 21
Material Frayed 21 21
Device Appears to Trigger Rejection 20 20
Unexpected Therapeutic Results 19 19
Structural Problem 19 19
Peeled/Delaminated 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Physical Resistance/Sticking 14 14
Unsealed Device Packaging 13 13
Difficult to Remove 13 13
Deformation Due to Compressive Stress 12 12
Material Fragmentation 11 11
Failure to Osseointegrate 11 11
Off-Label Use 11 11
Material Puncture/Hole 11 11
Detachment Of Device Component 11 11
Failure To Adhere Or Bond 10 10
Nonstandard Device 9 9
Contamination /Decontamination Problem 9 9
Folded 9 9
Extrusion 9 9
Human-Device Interface Problem 8 8
Unintended Movement 8 8
Loose or Intermittent Connection 8 8
Device Expiration Issue 8 8
Shelf Life Exceeded 7 7
Malposition of Device 7 7
Expulsion 6 6
Difficult to Open or Close 6 6
Retraction Problem 6 6
Device Slipped 6 6
Unraveled Material 6 6
Component Missing 6 6
Obstruction of Flow 6 6
Difficult to Insert 6 6
Sticking 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Damaged by Another Device 5 5
Positioning Problem 4 4
Protective Measures Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Too Rigid or Stiff 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Mechanical Problem 4 4
Hole In Material 3 3
Inflation Problem 3 3
Fracture 3 3
Crack 3 3
Material Rupture 3 3
Failure to Unfold or Unwrap 3 3
Device-Device Incompatibility 3 3
Compatibility Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Biocompatibility 2 2
Device Difficult to Maintain 2 2
Component Misassembled 2 2
Device Fell 2 2
Lack of Effect 2 2
Difficult or Delayed Positioning 2 2
Disconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 44260 44270
Injury 40947 40948
Insufficient Information 19236 19236
Hernia 19228 19233
Disability 17374 17374
Adhesion(s) 16921 16930
Unspecified Tissue Injury 10208 10208
Unspecified Infection 9338 9345
Inflammation 8027 8030
No Code Available 4868 4871
Scar Tissue 4419 4419
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4360 4360
Emotional Changes 4333 4334
Abdominal Pain 4021 4024
Obstruction/Occlusion 4002 4002
Abscess 3531 3533
Discomfort 3371 3372
Nausea 2946 2947
Seroma 2794 2797
Not Applicable 2763 2763
Erosion 1977 1980
Fistula 1950 1955
Scarring 1587 1589
Impaired Healing 1577 1580
Purulent Discharge 1409 1409
Abdominal Distention 1409 1409
Failure of Implant 1389 1390
Fluid Discharge 1349 1349
No Clinical Signs, Symptoms or Conditions 1329 1329
Foreign Body Reaction 1313 1315
Diarrhea 1260 1260
Nerve Damage 1135 1137
Hematoma 1125 1125
Chills 1064 1064
Necrosis 1022 1022
Decreased Appetite 1020 1020
Distress 982 982
Swelling/ Edema 929 929
Weight Changes 897 897
Ascites 896 896
Fibrosis 824 824
Discharge 799 799
Hemorrhage/Bleeding 799 799
Vomiting 750 751
Deformity/ Disfigurement 646 646
Bacterial Infection 622 622
Swelling 571 571
No Information 562 562
Fever 521 521
Perforation 502 502
Blood Loss 472 472
Wound Dehiscence 433 433
Constipation 423 423
Erythema 407 407
No Consequences Or Impact To Patient 387 387
Cellulitis 378 378
Muscle Weakness 366 366
Nodule 352 352
Incontinence 336 336
Granuloma 335 336
Sepsis 293 294
Urinary Tract Infection 292 292
Bowel Perforation 251 251
Urinary Retention 250 250
Post Operative Wound Infection 239 240
Prolapse 237 237
Depression 211 211
Burning Sensation 207 207
Numbness 194 194
Ischemia 187 187
Anxiety 184 184
Death 183 183
Staphylococcus Aureus 181 181
Hypersensitivity/Allergic reaction 177 178
Edema 172 173
Cyst(s) 171 171
Internal Organ Perforation 170 170
Foreign Body In Patient 170 170
Ulcer 147 147
Cramp(s) /Muscle Spasm(s) 143 143
Reaction 137 138
Fatigue 129 129
Urinary Frequency 128 128
Ambulation Difficulties 124 124
Rash 117 117
No Known Impact Or Consequence To Patient 115 115
Tissue Damage 112 115
Micturition Urgency 104 104
Dysuria 104 104
Skin Inflammation/ Irritation 104 104
Tachycardia 99 99
Sexual Dysfunction 95 95
Hematuria 95 95
Peritonitis 94 94
Neuropathy 85 85
Sleep Dysfunction 85 85
Pneumonia 82 82
Weakness 81 81
Low Blood Pressure/ Hypotension 81 82
Thrombosis/Thrombus 80 80

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Feb-23-2018
2 Covidien LLC II Nov-14-2018
3 Covidien LLC II Jul-12-2018
4 Covidien Llc II Feb-22-2021
5 Covidien, LP II Feb-27-2023
6 Davol, Inc. II Jul-27-2023
7 Ethicon, Inc. II Dec-03-2020
8 Sofradim Production II Apr-26-2018
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