MAUDE Adverse Event Report: GELESIS, INC. PLENITY; DELIVERY SYSTEM

Model Number MC0420

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  Injury  

Event Description

Hospitalized due to hiatal hernia [hiatus hernia].Case narrative: this initial spontaneous report, was received from the united states of america initially reported by a physician on 22-jan-2021 and 03-feb-2021.A (b)(6) female patient (weight 104.3 kg) reported hiatal hernia while on plenity for an unknown indication.The patient¿s medical history included hypertension.The patient's concomitant medications included lisinopril and hydrochlorothiazide.On (b)(6) 2021, the patient was prescribed with plenity, but it was not confirmed when the patient started taking plenity.On an unspecified date, the patient started the therapy with plenity three capsules by mouth with 16 ounces (2 glasses) of water 20 to 30 minutes before lunch and dinner for weight management.The lot number and expiry date of plenity were not reported.On an unspecified date, the patient experienced hiatal hernia and was hospitalized.Treatment medication and laboratory details were unknown at the time of this report.Action taken: patient discontinued plenity as a result of the event (hiatal hernia).Outcome of the event was unknown at the time of this report.The case was considered as serious due to the hospitalization.This case was verified by a healthcare professional.Company comment: this spontaneous report by a physician refers to a (b)(6) female patient, (b)(6), was admitted for hiatal hernia while on plenity.Medical history included hypertension and concomitant medications included lisinopril and hydrochlorothiazide.Patient was prescribed plenity on 04-jan-2021, but it was not confirmed when patient started taking plenity.On an unknown date, the patient was hospitalized for hiatal hernia.The case was considered as serious due to hospitalization.The report lacks details on duration of plenity therapy, signs, symptoms, clinical course of the event in the hospital, treatment, diagnostic workup, action taken with plenity, outcome of the event, any additional medical/surgical history; therefore, precludes a meaningful medical assessment.Nevertheless, due to the spontaneous nature of the report, causality of the event to plenity was assessed as possibly related.Additional information has been requested and the assessments are subject to change when relevant follow up information is received.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188 calimera (le); puglia, it 73021
• MDR Report Key: 11341785
• MDR Text Key: 232334880
• Report Number: 3012121187-2021-00247
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Device Catalogue Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• 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: N
• Patient Sequence Number: 1
• Treatment: HCTZ (HCTZ),; LISINOPRIL (LISINOPRIL),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104