TPLC - Total Product Life Cycle

• Device: orthosis, limb brace
• Regulation Description: Limb orthosis.
• Product Code: IQI
• Regulation Number: 890.3475
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	11	11
2021	9	9
2022	11	11
2023	3	3
2024	2	2
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	19	19
Patient Device Interaction Problem	5	5
Inadequacy of Device Shape and/or Size	2	2
Break	1	1
Device Markings/Labelling Problem	1	1
Device Fell	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Material Separation	1	1
Fracture	1	1
Human-Device Interface Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Itching Sensation	11	11
Erythema	9	9
Skin Inflammation/ Irritation	8	8
Skin Irritation	4	4
Rash	4	4
Pain	4	4
Unspecified Infection	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Blister	3	3
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Abrasion	2	2
Nerve Damage	2	2
Insufficient Information	2	2
Fall	2	2
Bruise/Contusion	2	2
Patient Problem/Medical Problem	1	1
Skin Infection	1	1
Fungal Infection	1	1
No Code Available	1	1
Necrosis	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Muscle Weakness	1	1
Localized Skin Lesion	1	1
Burn(s)	1	1
Irritation	1	1
Swelling	1	1
Numbness	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Muscle/Tendon Damage	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Skin Burning Sensation	1	1
External Prosthetic Device Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Townsend Design	II	Jan-05-2024