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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ureteral, general & plastic surgery
Product CodeGBL
Regulation Number 876.5130
Device Class Not Classified

MDR Year MDR Reports MDR Events
2019 15 15
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5 5
Contamination /Decontamination Problem 2 2
Detachment of Device or Device Component 2 2
Break 2 2
Fracture 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Difficult to Advance 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Unspecified Infection 1 1
Perforation 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-04-2020
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