MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/12/2022

Event Type  Injury  

Event Description

Gallbladder attack [gallbladder disorder].Case narrative: this initial spontaneous report was received from the united states of america reported by a ro physician on (b)(6) 2022.A 47-year-old female patient (weight: 180 lbs) experienced gallbladder disorder while on plenity for elevated bmi (weight management).The patient¿s surgical history included: c-section, hysterectomy, cyst removal, tummy tuck, gallbladder removal and cholecystectomy; historical condition included tachycardia and drug allergies and other medical device usage were not reported.The concomitant medications included metoprolol tartrate (film coated tablet), baclofen, duloxetine hydrochloride (delayed release capsule), buspirone hydrochloride (tablet) and collagen.On (b)(6) 2022, the patient started oral therapy with plenity at a dose of three capsules twice daily before lunch and dinner for elevated bmi (weight management).The lot number and expiry date of plenity were not reported.On (b)(6) 2022 (reported as sunday night) after taking plenity for four days, the patient went to the emergency room due to a gallbladder attack (pt: gallbladder disorder).The patient was hospitalized and underwent cholecystectomy (removal of gallbladder) and was discharged from the hospital on (b)(6) 2022.This case was assessed as serious based on the seriousness criteria of hospitalization and intervention (cholecystectomy).On an unspecified date, the patient discontinued (cancelled) plenity and was recommended for follow up.Action taken: patient discontinued plenity as a result of event gallbladder disorder.The outcome of the event gallbladder disorder was unknown.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 47-year-old female patient who experienced gallbladder disorder while on plenity for elevated bmi (weight management).The patient has a past medical history of tachycardia and past surgical history of c-section, hysterectomy, cyst removal and tummy tuck.Concomitant medications include metoprolol tartrate, baclofen, duloxetine hydrochloride, buspirone hydrochloride and collagen.The event occurred after 4 days of starting plenity and plenity was discontinued due to the event.The patient was taken to emergency for gall bladder disorder and a cholecystectomy was performed.This case is assessed as serious based on the seriousness criteria of hospitalization and intervention provided (cholecystectomy).The causality for the event is assessed as unlikely due to lack of pharmacological plausibility and the known indications of cholecystectomy being associated gall bladder disorders.

Event Description

Gallbladder attack [gallbladder disorder].Case narrative: this initial spontaneous report was received from the united states of america reported by a ro physician on 15-jun-2022.A 47-year-old female patient (weight: 180 lbs) experienced gallbladder disorder while on plenity for elevated bmi (weight management).The patient¿s surgical history included: c-section, hysterectomy, cyst removal, tummy tuck, gallbladder removal and cholecystectomy; historical condition included tachycardia and depression.Drug allergies and other medical device usage were not reported.The concomitant medications included metoprolol tartrate (film coated tablet), baclofen, duloxetine hydrochloride (delayed release capsule), buspirone hydrochloride (tablet) and collagen.On (b)(6) 2022, the patient started oral therapy with plenity at a dose of three capsules twice daily before lunch and dinner for elevated bmi (weight management).The lot number and expiry date of plenity were not reported.On 12-jun-2022 (reported as sunday night) after taking plenity for four days, the patient went to the emergency room due to a gallbladder attack (pt:gallbladder disorder).The patient was hospitalized and underwent cholecystectomy (removal of gallbladder) and was discharged from the hospital on 15-jun-2022.This case was assessed as serious based on the seriousness criteria of hospitalization and intervention (cholecystectomy).On an unspecified date, the patient discontinued (cancelled) plenity and was recommended for follow up.Action taken: patient discontinued plenity as a result of event gallbladder disorder the outcome of the event gallbladder disorder was unknown.This case was verified by a healthcare professional.Follow-up information received on 25-jul-2022 included: medical history was updated.Narrative amended.Company comment: this spontaneous report refers to a 47-year-old female patient who experienced gallbladder disorder while on plenity for elevated bmi (weight management).The patient has a medical history of depression and tachycardia and past surgical history of c-section, hysterectomy, cyst removal and tummy tuck.Concomitant medications include metoprolol tartrate, baclofen, duloxetine hydrochloride, buspirone hydrochloride and collagen.The event occurred after 4 days of starting plenity and plenity was discontinued due to the event.The patient was taken to emergency for gall bladder disorder and a cholecystectomy was performed.This case is assessed as serious based on the seriousness criteria of hospitalization and intervention provided (cholecystectomy).The causality for the event is assessed as unlikely due to lack of pharmacological plausability and the known indications of cholecystectomy being associated gall bladder disorders.Follow up information does not change the medical assessment of the case.

• 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: 14841836
• MDR Text Key: 295116730
• Report Number: 3012121187-2022-00373
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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
• Treatment: BACLOFEN (BACLOFEN), TABLET; BACLOFEN (BACLOFEN), TABLET; BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE); BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE); COLLAGEN (COLLAGEN); COLLAGEN (COLLAGEN); DULOXETINE (DULOXETINE); DULOXETINE (DULOXETINE); METOPROLOL TARTRATE (METOPROLOL TARTRATE); METOPROLOL TARTRATE (METOPROLOL TARTRATE)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG