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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, ostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXE
Regulation Number 876.5900
Device Class 1

Device Problems
No Known Device Problem 1003
Human-Device Interface Issue 290
Difficult to remove 145
Increased sensitivity 51
Device operates differently than expected 34
Leak 24
Sticking 19
No Information 17
Failure to Adhere or Bond 16
Material disintegration 10
Defective item 9
Material fragmentation 8
Patient-device incompatibility 7
Device abrasion from instrument or another object 6
No code available 6
Foreign material present in device 4
Material integrity issue 4
Material separation 4
Size incorrect for patient 3
Wrinkled 3
Melted 3
Material rigid or stiff 3
Device handling issue 3
Material deformation 2
Material discolored 2
Fluid leak 2
Use of Device Issue 2
Expulsion 2
Flare or flash 2
Delamination 2
Device markings issue 1
Slippage of device or device component 1
Buckled material 1
Fitting problem 1
Incomplete or missing packaging 1
Device Issue 1
Malposition of device 1
Folded 1
Unable to confirm conditions of use 1
Blockage within device or device component 1
Loss of or failure to bond 1
Degraded 1
Moisture damage 1
Occlusion within device 1
Difficult to position 1
User used incorrect product for intended use 1
Product quality issue 1
Reflux within device 1
Scratched material 1
Gas leak 1
Improper chemical reaction 1
Incompatibility problem 1
Total Device Problems 1708

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