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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor, vaginal
Product CodeHDL
Regulation Number 884.4520
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 3 3
2019 3 3
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1
Positioning Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 2 2
No Known Impact Or Consequence To Patient 2 2
Skin Burning Sensation 1 1
Insufficient Information 1 1
Skin Erosion 1 1
Discomfort 1 1
Injury 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Dry Eye(s) 1 1
Intraocular Pressure Increased 1 1
Laceration(s) 1 1
Peeling 1 1

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