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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
2019 3 3
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 2 2
Break 1 1
No Apparent Adverse Event 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4 4
Obstruction/Occlusion 2 2
Unspecified Infection 2 2
Pain 2 2
Perforation 1 1
Pocket Erosion 1 1
Urinary Retention 1 1
Wound Dehiscence 1 1
Erosion 1 1
Cyst(s) 1 1
Fistula 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Blood Loss 1 1
Swelling/ Edema 1 1

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