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TPLC
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Device
infant heel warmer (chemical heat pack)
Product Code
MPO
Regulation Number
890.5710
Device Class
1
Premarket Reviews
Manufacturer
Decision
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
8
8
2020
53
53
2021
20
20
2022
61
61
2023
74
74
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
140
140
Explosion
43
43
Material Rupture
20
20
Fluid/Blood Leak
10
10
Leak/Splash
6
6
Break
4
4
Gel Leak
4
4
Temperature Problem
4
4
Activation Problem
3
3
Device Difficult to Setup or Prepare
2
2
Activation Failure
2
2
Activation, Positioning or Separation Problem
1
1
Material Puncture/Hole
1
1
Insufficient Information
1
1
Defective Component
1
1
Defective Device
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Handling Problem
1
1
Material Separation
1
1
Appropriate Term/Code Not Available
1
1
Insufficient Heating
1
1
Unexpected Therapeutic Results
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
140
140
No Consequences Or Impact To Patient
40
40
No Known Impact Or Consequence To Patient
16
16
Insufficient Information
15
15
Chemical Exposure
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Information
2
2
Skin Inflammation/ Irritation
2
2
Burn(s)
2
2
Discomfort
2
2
Laceration(s)
2
2
Skin Irritation
1
1
Corneal Abrasion
1
1
Eye Burn
1
1
Erythema
1
1
Unspecified Eye / Vision Problem
1
1
Eye Injury
1
1
Fluid Discharge
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
Jul-17-2023
2
Cardinal Health 200, LLC
II
Jul-19-2021
3
Philips North America Llc
II
Jan-19-2022
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