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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mechanical compression device fecal incontinence (non-manually operated)
Definition For treatment of fecal incontinence in patients who have failed conservative therapies
Product CodePMH
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 1 1
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 1 1
Cyst(s) 1 1
Hematoma 1 1
Perforation 1 1
Obstruction/Occlusion 1 1
Urinary Retention 1 1
Pain 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Pocket Erosion 1 1
Fistula 1 1

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