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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, mattress (medical purposes)
Regulation Description Mattress cover for medical purposes.
Product CodeFMW
Regulation Number 880.6190
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2023 3 3
2024 4 4
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 1 1
Device-Device Incompatibility 1 1
Insufficient Information 1 1
Inadequate Instructions for Healthcare Professional 1 1
Sharp Edges 1 1
Material Rupture 1 1
Device Emits Odor 1 1
Inadequacy of Device Shape and/or Size 1 1
Appropriate Term/Code Not Available 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Fall 2 2
No Code Available 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Laceration(s) 1 1
Pain 1 1
Capsular Contracture 1 1

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