TPLC - Total Product Life Cycle

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Device	submucosal injection agent
Definition	Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Product Code	PLL
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	51	51
Break	5	5
Defective Device	5	5
Nonstandard Device	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	1	1
Material Fragmentation	1	1
Unsealed Device Packaging	1	1
Device Difficult to Setup or Prepare	1	1
Insufficient Flow or Under Infusion	1	1
Component Missing	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Granuloma	39	39
Fibrosis	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Inflammation	6	6
Muscle Spasm(s)	3	3
Local Reaction	3	3
No Consequences Or Impact To Patient	3	3
Hemorrhage/Bleeding	3	3
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	2	2
Obstruction/Occlusion	2	2
Bowel Perforation	2	2
Perforation	2	2
Scar Tissue	1	1
Tissue Breakdown	1	1
Stenosis	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Abdominal Pain	1	1
Arrhythmia	1	1
Dysphagia/ Odynophagia	1	1
Fever	1	1
Reaction to Medicinal Component of Device	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Nov-11-2022