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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device restraint, protective
Regulation Description Protective restraint.
Product CodeFMQ
Regulation Number 880.6760
Device Class 1

Device Problems
Break 24
Adverse Event Without Identified Device or Use Problem 19
Mechanical Problem 18
Device Contaminated during manufacture or shipping 11
Torn Material 9
Material Separation 7
Material Integrity Problem 6
Device Operates Differently Than Expected 6
Detachment Of Device Component 5
Insufficient Information 4
Material Rupture 4
Misassembled 4
Defective Component 3
Defective Device 3
Device Slipped 3
Detachment of Device or device Component 2
Difficult to Open or Close 2
Device Difficult to Setup or Prepare 1
Use of Device Problem 1
Structural Problem 1
Escape 1
Stretched 1
Inadequacy of Device Shape and/or Size 1
Total Device Problems 136

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Mar-14-2014
2 Med Tec Inc II Sep-14-2015
3 Med Tec Inc II Jan-15-2015

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