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 Perforation (2001)

Event Type  Injury  

Event Description

He had 2 perforations [perforation] colon infection/diverticulitis [diverticulitis].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2021.A (b)(6) male patient (weight 225 lbs) experienced diverticulitis and perforation while on plenity for obesity.The patients medical history, concurrent conditions were not reported.The patient had no known drug allergies.The patients concomitant medications included advil (ibuprofen) and over the counter(otc) medications.The patient denied any other medical conditions.The patient had no history of gastrointestinal tract issues.On an unspecified date, the patient started therapy with plenity (0.75 g) three capsules by mouth taken twice for obesity.The lot number and expiry date of plenity were not reported.On an unspecified date (after taking plenity), the patient experienced severe abdominal pain and stopped taking plenity for a couple of weeks and pain was resolved.On an unspecified date, the patient resumed taking plenity and experienced pain again.After taking one dose, the patient stopped taking plenity and the pain was not resolved.On an unspecified date,colon infection/diverticulitis (pt: diverticulitis) was diagnosed to the patient and sent home with antibiotics (unspecified).A week later the patient came to the emergency room and received stronger antibiotics through the intravenous route as a treatment medication.It was unknown whether the diagnostic tests were performed or not.On (b)(6) 2021, the patient was admitted to the hospital and stayed about 3 days and informed that he had 2 perforations (pt: perforation) and required surgery for bowel perforations.It was unknown whether the condition of the patient was improved or not.However, he felt that events were related to plenity therapy.On (b)(6) 2021, it was reported that there was no follow-up from the patient until the check-in visit and no change in prescription.Action taken: the patient discontinued plenity as a result of the events (diverticulitis and perforation).The outcome of the events diverticulitis and perforation were unknown at the time of this report.The case was assessed as serious due to hospitalization.This case was not verified by a healthcare professional.Company comment: this spontaneous case refers to a (b)(6) male patient who experienced diverticulitis complicated with perforation while on therapy with plenity for obesity.Patient experienced first episode of abdominal pain after starting therapy with plenity, which resolved after withholding the drug for a couple of weeks.Upon restarting plenity, abdominal pain recurred after a single dose and plenity was discontinued again.However, this time pain didn't subside and he was diagnosed with diverticulitis.He was started on antibiotic therapy and sent home.Lack of symptomatic improvement resulted in er visit a week later and hospitalization due to perforation, for which surgery was recommended.Medical history was not significant for any gastrointestinal diseases.Concomitant medications include over the counter drugs and advil for unknown indication.The case is assessed as serious based on hospitalization and the recommended surgical intervention.Based on the reasonable temporal relationship and positive dechallenge, causality is assessed as possible.Diverticulitis could have complicated further resulting in perforation.However, more details regarding concomitant medications and investigations summary is required for proper 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: 12055863
• MDR Text Key: 258060336
• Report Number: 3012121187-2021-00354
• 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: consumer
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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
• 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: ADVIL (IBUPROFEN),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 102