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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device pouch, colostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEZQ
Regulation Number 876.5900
Device Class 1

Device Problems
Malposition of device 441
Adverse Event Without Identified Device or Use Problem 265
Difficult to Remove 63
Human-Device Interface Problem 55
Defective Device 11
Leak / Splash 11
Material Too Rigid or Stiff 10
Device Operates Differently Than Expected 10
Product Quality Problem 10
Sticking 9
Device Markings / Labelling Problem 5
Failure To Adhere Or Bond 5
Increased Sensitivity 4
Material Disintegration 3
Incomplete or Missing Packaging 3
Device Handling Problem 3
Device Contamination with Chemical or Other Material 2
Material Deformation 2
Scratched Material 2
Packaging Problem 2
Fluid Leak 2
Inflation Problem 2
Activation Failure Including Expansion Failures 2
Delamination 2
Appropriate Term/Code Not Available 2
Loss of or Failure to Bond 1
Deflation Problem 1
Material Puncture / Hole 1
Use of Device Problem 1
Component Missing 1
Misassembled 1
Occlusion Within Device 1
Defective Component 1
Nonstandard device 1
Insufficient Information 1
Crack 1
Material Rupture 1
Dull, Blunt 1
Inadequacy of Device Shape and/or Size 1
Off-Label Use 1
Total Device Problems 941


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