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TPLC
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Device
tape and bandage, adhesive
Regulation Description
Medical adhesive tape and adhesive bandage.
Product Code
KGX
Regulation Number
880.5240
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
1290
1290
2021
560
560
2022
253
253
2023
192
192
2024
224
235
2025
145
159
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
996
996
Loss of or Failure to Bond
642
651
Material Integrity Problem
151
151
Insufficient Information
80
80
Patient-Device Incompatibility
57
57
Device Slipped
54
54
Contamination /Decontamination Problem
49
49
Detachment of Device or Device Component
49
49
Biocompatibility
47
47
Patient Device Interaction Problem
47
47
Delivered as Unsterile Product
39
39
Appropriate Term/Code Not Available
34
34
Product Quality Problem
32
32
Migration
30
30
Nonstandard Device
29
29
Device Dislodged or Dislocated
24
24
Unintended Movement
20
20
Defective Device
20
20
Packaging Problem
18
18
Physical Resistance/Sticking
17
17
Material Separation
16
16
Peeled/Delaminated
15
15
Material Disintegration
14
14
Unsealed Device Packaging
14
14
Difficult to Remove
14
14
Defective Component
13
13
Use of Device Problem
13
13
Contamination
11
11
Leak/Splash
10
10
Material Deformation
10
10
Difficult to Open or Close
9
25
Device Contaminated During Manufacture or Shipping
9
9
Device Contamination with Chemical or Other Material
8
8
Manufacturing, Packaging or Shipping Problem
8
8
Separation Problem
7
7
Failure to Obtain Sample
7
7
Moisture Damage
6
6
Device Difficult to Setup or Prepare
6
6
Difficult to Open or Remove Packaging Material
5
5
Improper or Incorrect Procedure or Method
5
5
Tear, Rip or Hole in Device Packaging
4
4
Failure to Unfold or Unwrap
4
4
Adhesive Too Strong
4
4
Problem with Sterilization
4
4
Therapeutic or Diagnostic Output Failure
3
3
Break
3
3
Microbial Contamination of Device
3
3
Mechanical Problem
3
3
Component Missing
3
3
Missing Information
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
631
656
No Known Impact Or Consequence To Patient
466
466
Injury
257
257
No Consequences Or Impact To Patient
203
203
Skin Inflammation/ Irritation
192
192
Unspecified Infection
189
189
Rash
183
183
Hypersensitivity/Allergic reaction
155
155
Itching Sensation
136
136
Skin Tears
124
124
Erythema
115
115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
114
114
Blister
104
104
Pain
84
84
Hemorrhage/Bleeding
48
48
Burning Sensation
45
45
Skin Infection
45
45
Local Reaction
44
44
Insufficient Information
43
43
No Code Available
43
43
Abrasion
43
43
Unspecified Tissue Injury
43
43
Skin Irritation
42
42
Peeling
40
40
Bacterial Infection
35
35
Skin Burning Sensation
32
32
Skin Discoloration
32
32
Contact Dermatitis
30
30
Swelling/ Edema
28
28
Fluid Discharge
27
27
No Patient Involvement
26
26
Purulent Discharge
24
24
Post Operative Wound Infection
21
21
Impaired Healing
21
21
Scar Tissue
20
20
Caustic/Chemical Burns
19
19
Burn(s)
17
17
Failure of Implant
15
15
Reaction
14
14
Wound Dehiscence
14
14
Wheal(s)
13
13
Localized Skin Lesion
13
13
Tissue Breakdown
13
13
Urticaria
12
12
Dyspnea
8
8
Ulcer
8
8
Discomfort
8
8
Skin Erosion
8
8
Inflammation
7
7
Cellulitis
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Apr-24-2024
2
3M Company - Health Care Business
II
Apr-03-2024
3
ASO LLC
II
May-02-2023
4
Cardinal Health 200, LLC
II
May-16-2024
5
Family Dollar Stores, Llc.
II
Aug-17-2022
6
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
7
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
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