TPLC - Total Product Life Cycle

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Device	suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Description	Stainless steel suture.
Product Code	GAQ
Regulation Number	878.4495
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	249	254
Break	173	173
Detachment of Device or Device Component	58	58
Adverse Event Without Identified Device or Use Problem	23	23
Device Contaminated During Manufacture or Shipping	9	9
Material Twisted/Bent	8	8
Defective Component	7	7
Dull, Blunt	6	6
Delivered as Unsterile Product	5	5
Product Quality Problem	4	4
Packaging Problem	3	3
Insufficient Information	2	2
Material Integrity Problem	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	2	2
Disconnection	1	1
Material Frayed	1	1
Entrapment of Device	1	1
Physical Resistance/Sticking	1	1
Separation Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Misfire	1	1
Component Missing	1	1
Migration	1	1
Corroded	1	1
Loose or Intermittent Connection	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	444	449
Insufficient Information	36	36
Hemorrhage/Bleeding	24	24
Wound Dehiscence	8	8
Tissue Breakdown	8	8
Foreign Body In Patient	7	7
Bone Fracture(s)	6	6
Pain	5	5
Unspecified Infection	4	4
Hypersensitivity/Allergic reaction	3	3
Itching Sensation	2	2
Rupture	2	2
Rash	2	2
Unintended Radiation Exposure	2	2
Urticaria	1	1
Impaired Healing	1	1
Purulent Discharge	1	1
Osteopenia/ Osteoporosis	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Needle Stick/Puncture	1	1
Erythema	1	1
Hernia	1	1
Renal Impairment	1	1
Pneumonia	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022