MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulcer (2274); Hematemesis (4478)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Throwing up blood [haematemesis]; sore in the lining of intestines [intestinal ulcer].Case narrative: this initial spontaneous report was received from the united states of america.Gelesis became aware of this event on 07-feb-2022 through a letter and medwatch report received from the usfda (fda report no: mw5106174).This case description is based on the information summarized in that report.A female patient of an unknown age reported vomiting blood and intestinal ulcer while on plenity for an unknown indication.The patient¿s medical history, concurrent conditions, concomitant medications, drug allergies and usage of other medical devices were not provided.On an unknown date (few days ago), the patient started therapy with plenity at an unknown dose, route and frequency for an unknown indication.Lot number and expiry date of plenity were not reported.It was reported that the patient was on plenity for a day or two days.It was reported that the patient started plenity in (b)(6) 2021.On (b)(6) 2021, the patient threw up a large amount of blood in toilet (pt: hematemesis) and the patient's husband rushed the patient to the hospital and the patient was kept overnight.The patient reported that a sore was found in the lining of intestines (pt: intestinal ulcer).The following day, the patient underwent cauterization.On an unknown date, the patient was recovering at home and still had an intravenous (iv) bandage.On an unknown date, the patient disposed of the remaining bottle of plenity.The case was considered serious due to hospitalization and intervention required (cauterization) to arrest bleeding.Therapy status of plenity was unknown at the time of this report.Outcome of the events hematemesis and intestinal ulcer was resolving.This case was verified by a healthcare professional.Company comment: this spontaneous case reported by pharmacist via usfda refers to a female patient of an unknown age who reported hematemesis and intestinal ulcer a day or two after starting plenity for an unknown indication.Patient reported throwing up a large amount of blood for which she was hospitalized and underwent cauterization the next morning to arrest bleeding.She was found to have an intestinal ulcer, the exact location of which was not reported.Therapy with plenity was discontinued and was never restarted.She was discharged home and is currently recovering.Medical history and concomitant medications are not reported.The case is assessed as serious due to hospitalization and intervention required (cauterization) to arrest bleeding.Based on the reasonable temporal relationship, causality is assessed as possible for hematemesis.Although, underlying intestinal ulcer could have contributed to the event, role of plenity could not be completely ruled out.Considering very short latency (1 or 2 days) in the development of intestinal ulcer, lack of medical history and concomitant medications, intestinal ulcer is assessed as unlikely related to plenity.Case will be reassessed based on the follow-up information.Hematemesis and intestinal ulcer are unlisted as per the current rsi.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): GELESIS SRL; via verdi, 188; calimera (le) 73021 ; IT 73021
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188; calimera (le) 73021
• MDR Report Key: 13597867
• MDR Text Key: 290795021
• Report Number: 3012121187-2022-00001
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female