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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, obstetrical
Product CodeHDA
Regulation Number 884.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
DIMEDA INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 23 23
2015 6 6
2016 3 3
2017 32 32
2018 30 30
2019 20 20
2020 15 15
2021 21 21
2022 13 13
2023 30 30
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 104 104
Detachment of Device or Device Component 50 50
Detachment Of Device Component 27 27
Difficult to Open or Close 24 24
Mechanical Problem 22 22
Failure to Align 13 13
Physical Resistance/Sticking 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Difficult to Remove 5 5
Material Twisted/Bent 4 4
Entrapment of Device 3 3
Peeled/Delaminated 2 2
Product Quality Problem 2 2
Component Missing 2 2
Physical Resistance 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Material Split, Cut or Torn 2 2
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Device Fell 1 1
Defective Device 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Difficult to Insert 1 1
Crack 1 1
Disconnection 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 75 75
No Clinical Signs, Symptoms or Conditions 56 56
No Consequences Or Impact To Patient 31 31
No Patient Involvement 13 13
Foreign Body In Patient 8 8
Unintended Radiation Exposure 7 7
No Code Available 6 6
Insufficient Information 5 5
No Information 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Abnormal Vaginal Discharge 2 2
Discomfort 2 2
Hematuria 2 2
Emotional Changes 2 2
Erythema 2 2
Abdominal Pain 2 2
Nausea 2 2
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Constipation 2 2
Syncope/Fainting 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Fluid Discharge 2 2
Dysuria 1 1
Radiation Exposure, Unintended 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Muscle Weakness 1 1
Blood Loss 1 1
Injury 1 1
Sleep Dysfunction 1 1
Dizziness 1 1
Anxiety 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Apr-23-2019
2 Fetzer Medical GmbH & Co. KG II Jan-18-2019
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