TPLC - Total Product Life Cycle

• Device: restraint, protective
• Product Code: FMQ
• Regulation Number: 880.6760
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
CHILDREN'S HEALTH FIRST, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDI-TECH INTL. CORP.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	43	43
2015	33	33
2016	24	24
2017	54	54
2018	23	23
2019	57	57
2020	38	38
2021	33	33
2022	54	54
2023	47	47
2024	21	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	117	117
Adverse Event Without Identified Device or Use Problem	46	46
Device Slipped	34	34
Mechanical Problem	30	30
Insufficient Information	18	18
Material Split, Cut or Torn	15	15
Device Operates Differently Than Expected	14	14
Torn Material	13	13
Material Integrity Problem	12	12
Improper or Incorrect Procedure or Method	12	12
Device Contaminated During Manufacture or Shipping	11	11
Material Separation	9	9
Defective Device	9	9
Defective Component	8	8
Patient Device Interaction Problem	7	7
Detachment Of Device Component	7	7
Detachment of Device or Device Component	6	6
Mechanics Altered	6	6
Product Quality Problem	6	6
Material Frayed	5	5
Positioning Problem	5	5
Labelling, Instructions for Use or Training Problem	5	5
Material Rupture	4	4
Misassembled	4	4
Material Disintegration	4	4
Human-Device Interface Problem	4	4
Fail-Safe Problem	3	3
Connection Problem	3	3
Difficult to Open or Close	3	3
Stretched	3	3
Microbial Contamination of Device	2	2
Inadequacy of Device Shape and/or Size	2	2
Protective Measures Problem	2	2
No Apparent Adverse Event	2	2
Therapeutic or Diagnostic Output Failure	2	2
Use of Device Problem	2	2
Degraded	2	2
Difficult or Delayed Separation	2	2
Appropriate Term/Code Not Available	2	2
Activation, Positioning or Separation Problem	2	2
Unraveled Material	2	2
Inadequate Instructions for Healthcare Professional	1	1
Device Difficult to Setup or Prepare	1	1
Structural Problem	1	1
Escape	1	1
Difficult to Remove	1	1
Tear, Rip or Hole in Device Packaging	1	1
Off-Label Use	1	1
Device Emits Odor	1	1
Device Handling Problem	1	1
Sticking	1	1
Unintended Movement	1	1
Nonstandard Device	1	1
Crack	1	1
Material Too Soft/Flexible	1	1
Disconnection	1	1
Moisture Damage	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
No Consequences Or Impact To Patient	95	95
No Known Impact Or Consequence To Patient	59	59
Extubate	34	34
Insufficient Information	19	19
No Patient Involvement	15	15
Fall	12	12
No Code Available	10	10
No Information	9	9
Not Applicable	6	6
Skin Tears	6	6
Death	6	6
Emotional Changes	5	5
Irritability	5	5
Bruise/Contusion	4	4
Skin Erosion	4	4
Bone Fracture(s)	3	3
Loss of consciousness	3	3
Injury	3	3
Confusion/ Disorientation	3	3
Choking	2	2
Skin Irritation	2	2
Laceration(s)	2	2
Anxiety	2	2
Unintended Extubation	2	2
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1
Therapeutic Response, Decreased	1	1
Pain	1	1
Paresis	1	1
Concussion	1	1
Head Injury	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Irritation	1	1
Cardiopulmonary Arrest	1	1
Blood Loss	1	1
Device Embedded In Tissue or Plaque	1	1
Fracture, Arm	1	1
Ventilator Dependent	1	1
Reinfusion	1	1
Numbness	1	1
Abrasion	1	1
Sweating	1	1
Needle Stick/Puncture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Aug-22-2022
2	DeRoyal Industries Inc	II	Mar-30-2020
3	DeRoyal Industries Inc	II	Mar-14-2014
4	J T Posey Company	II	Apr-09-2013
5	J T Posey Company	II	Sep-22-2009
6	J T Posey Company	II	Feb-03-2009
7	Med Tec Inc	II	Sep-14-2015
8	Med Tec Inc	II	Jan-15-2015
9	Queen Comfort Products lLC	II	Nov-01-2021
10	TIDI PRODUCTS	II	Oct-25-2019