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TPLC
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show TPLC since
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Device
pack, hot or cold, disposable
Product Code
IMD
Regulation Number
890.5710
Device Class
1
Premarket Reviews
Manufacturer
Decision
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
632
632
2020
248
248
2021
142
142
2022
202
202
2023
184
184
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
377
377
Leak/Splash
179
179
Burst Container or Vessel
167
167
Insufficient Information
160
160
Use of Device Problem
135
135
Improper or Incorrect Procedure or Method
103
103
Break
78
78
Excessive Heating
77
77
Patient-Device Incompatibility
76
76
Overheating of Device
44
44
Unintended Ejection
40
40
Fluid/Blood Leak
33
33
Nonstandard Device
33
33
Material Rupture
33
33
Explosion
29
29
Defective Device
28
28
Appropriate Term/Code Not Available
27
27
Temperature Problem
25
25
Insufficient Heating
25
25
Loss of or Failure to Bond
18
18
Material Deformation
16
16
Material Protrusion/Extrusion
11
11
Product Quality Problem
11
11
Off-Label Use
10
10
Material Puncture/Hole
9
9
Material Integrity Problem
9
9
Therapeutic or Diagnostic Output Failure
9
9
Material Split, Cut or Torn
8
8
Physical Resistance/Sticking
8
8
Device Markings/Labelling Problem
7
7
Difficult to Remove
7
7
Unsealed Device Packaging
6
6
Patient Device Interaction Problem
6
6
Unexpected Therapeutic Results
5
5
Expiration Date Error
4
4
Defective Component
4
4
Packaging Problem
4
4
Activation Problem
4
4
Output Problem
3
3
Component Missing
3
3
Device Damaged Prior to Use
3
3
Activation, Positioning or Separation Problem
3
3
Device Emits Odor
3
3
Gel Leak
3
3
Moisture Damage
3
3
Labelling, Instructions for Use or Training Problem
2
2
Premature Activation
2
2
Material Separation
2
2
Fitting Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Detachment of Device or Device Component
2
2
Incomplete or Missing Packaging
2
2
Manufacturing, Packaging or Shipping Problem
2
2
No Pressure
1
1
Material Twisted/Bent
1
1
Protective Measures Problem
1
1
Activation Failure
1
1
Noise, Audible
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Connection Problem
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Inadequate User Interface
1
1
Short Fill
1
1
Self-Activation or Keying
1
1
Device Difficult to Setup or Prepare
1
1
Increase in Pressure
1
1
Peeled/Delaminated
1
1
Material Too Rigid or Stiff
1
1
Loose or Intermittent Connection
1
1
Melted
1
1
Crack
1
1
Material Discolored
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Fire
1
1
Difficult or Delayed Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Partial thickness (Second Degree) Burn
291
291
Burn, Thermal
239
241
No Known Impact Or Consequence To Patient
189
189
Pain
166
166
No Clinical Signs, Symptoms or Conditions
164
164
Burn(s)
112
112
Chemical Exposure
83
83
Erythema
77
77
Swelling
68
68
Burning Sensation
52
52
Itching Sensation
50
50
Insufficient Information
48
48
Rash
43
43
Blister
42
42
Superficial (First Degree) Burn
41
41
Skin Irritation
37
37
Discomfort
30
30
Scarring
28
28
Skin Discoloration
27
27
Injury
27
27
Full thickness (Third Degree) Burn
21
21
Hypersensitivity/Allergic reaction
20
20
No Consequences Or Impact To Patient
18
18
Peeling
18
18
Skin Tears
16
16
Ulcer
14
14
Scar Tissue
14
14
Abrasion
13
13
Urticaria
13
13
No Code Available
13
13
Skin Burning Sensation
12
12
Skin Inflammation/ Irritation
12
12
Patient Problem/Medical Problem
12
12
Irritation
12
12
Tissue Damage
11
11
Skin Inflammation
10
10
Hemorrhage/Bleeding
9
9
Caustic/Chemical Burns
8
8
Tissue Breakdown
7
7
Reaction
7
7
Inflammation
7
7
Red Eye(s)
7
7
Tingling
6
6
Bruise/Contusion
6
6
No Information
6
6
Swelling/ Edema
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Sleep Dysfunction
5
5
Contusion
5
5
Unspecified Infection
5
5
Death
4
4
Purulent Discharge
4
4
Exposure to Body Fluids
4
4
Skin Infection
4
4
Complaint, Ill-Defined
3
3
Impaired Healing
3
3
Blood Loss
3
3
Eye Injury
3
3
Dyspnea
3
3
Foreign Body Sensation in Eye
3
3
Rupture
3
3
Skin Erosion
3
3
Blurred Vision
2
2
Cramp(s)
2
2
Therapeutic Effects, Unexpected
2
2
Local Reaction
2
2
Increased Sensitivity
2
2
Necrosis
2
2
Muscle Spasm(s)
2
2
Emotional Changes
2
2
Fall
2
2
Abdominal Pain
2
2
Abscess
2
2
Chest Pain
2
2
No Patient Involvement
2
2
Discharge
2
2
Alteration In Body Temperature
2
2
Fluid Discharge
2
2
Eye Burn
2
2
Sweating
2
2
Numbness
2
2
Eye Pain
2
2
Localized Skin Lesion
2
2
Skin Disorders
1
1
Cryogenic Burn
1
1
Hyperesthesia
1
1
Contact Dermatitis
1
1
Unspecified Tissue Injury
1
1
Collapse
1
1
Neck Stiffness
1
1
Inadequate Pain Relief
1
1
Disability
1
1
Dysuria
1
1
Device Embedded In Tissue or Plaque
1
1
Ambulation Difficulties
1
1
Vascular System (Circulation), Impaired
1
1
Corneal Abrasion
1
1
Dry Eye(s)
1
1
Dehydration
1
1
Adhesion(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperSurgical, Inc.
II
Aug-24-2019
2
PF Consumer Healthcare 1 LLC
II
May-28-2019
3
Philips North America Llc
II
Jan-19-2022
4
Philips North America Llc
II
Jan-18-2022
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