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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 106 106
Detachment of Device or Device Component 53 53
Detachment Of Device Component 27 27
Difficult to Open or Close 25 25
Mechanical Problem 22 22
Failure to Align 13 13
Physical Resistance/Sticking 6 6
Difficult to Remove 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Material Twisted/Bent 4 4
Entrapment of Device 3 3
Material Split, Cut or Torn 2 2
Peeled/Delaminated 2 2
Component Missing 2 2
Mechanics Altered 2 2
Physical Resistance 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Disconnection 1 1
Crack 1 1
Collapse 1 1
Insufficient Information 1 1
Device Fell 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Insert 1 1
Material Protrusion/Extrusion 1 1
Human-Device Interface Problem 1 1
Device Operates Differently Than Expected 1 1
Noise, Audible 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 59 59
No Consequences Or Impact To Patient 31 31
No Patient Involvement 13 13
Foreign Body In Patient 8 8
Unintended Radiation Exposure 8 8
No Code Available 6 6
Insufficient Information 5 5
No Information 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Abdominal Pain 2 2
Syncope/Fainting 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Emotional Changes 2 2
Nausea 2 2
Abnormal Vaginal Discharge 2 2
Hematuria 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Erythema 2 2
Discomfort 2 2
Pain 2 2
Fluid Discharge 2 2
Constipation 2 2
Device Embedded In Tissue or Plaque 2 2
Sleep Dysfunction 1 1
Radiation Exposure, Unintended 1 1
Dysuria 1 1
Dizziness 1 1
Muscle Weakness 1 1
Blood Loss 1 1
Purulent Discharge 1 1
Cellulitis 1 1
Injury 1 1
Anxiety 1 1
Hemorrhage/Bleeding 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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