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TPLC
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show TPLC since
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Device
forceps, surgical, gynecological
Product Code
HCZ
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
FETZER MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
INSTRUMED INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2017
1
1
2018
3
3
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
8
8
Device Inoperable
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
Material Twisted/Bent
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Device Interaction Problem
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4
4
No Consequences Or Impact To Patient
3
3
No Known Impact Or Consequence To Patient
3
3
No Information
3
3
Insufficient Information
1
1
Pain
1
1
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