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TPLC
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show TPLC since
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Device
speculum, vaginal, nonmetal
Product Code
HIB
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
CLEARSPEC LLC
SUBSTANTIALLY EQUIVALENT
1
IOB MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
KOLPLAST CI LTDA
SUBSTANTIALLY EQUIVALENT
1
KUNSHAN DEYI PLASTIC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OBP CORPORATION
SUBSTANTIALLY EQUIVALENT
1
PROA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
WELCH ALLYN, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
5
5
2016
1
1
2017
5
5
2018
3
3
2019
4
4
2020
4
4
2021
4
4
2022
2
2
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
20
20
Shipping Damage or Problem
8
8
Fracture
6
6
Crack
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Separation
2
2
Physical Property Issue
1
1
No Apparent Adverse Event
1
1
Electrical /Electronic Property Problem
1
1
Detachment Of Device Component
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Laceration(s)
11
11
Vaginal Mucosa Damage
9
9
No Known Impact Or Consequence To Patient
6
6
No Clinical Signs, Symptoms or Conditions
5
5
No Consequences Or Impact To Patient
3
3
Abrasion
2
2
No Code Available
2
2
Insufficient Information
2
2
Burn, Thermal
2
2
Pain
1
1
Device Embedded In Tissue or Plaque
1
1
Discomfort
1
1
Patient Problem/Medical Problem
1
1
No Information
1
1
Foreign Body In Patient
1
1
Corneal Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperSurgical, Inc.
II
Jun-22-2015
2
Welch Allyn Inc
II
Oct-30-2015
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