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 Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Bowel Perforation (2668); Constipation (3274)

Event Type  Injury  

Event Description

Rupture in intestines [gastrointestinal perforation]; bowel obstruction [intestinal obstruction]; reduced dose to 1 capsule instead of 3 [off label use].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer (patient's daughter) on (b)(6) 2022.A (b)(6) male patient (weight: (b)(6)) reported bowel obstruction, gastrointestinal perforation and off label dosing while on plenity for weight loss.The patient¿s initial weight was (b)(6) and had no change medical history, current conditions, concomitant medications, drug allergies and any other usage of medical devices.On (b)(6) 2022, the patient started therapy with plenity at a dose of 3 capsules, twice daily, 20 minutes prior to lunch and dinner meals with 16 oz of water for weight loss.Lot number and expiry date of plenity were not provided as the patient was in a different location.The patient followed diet and exercise while on plenity.On an unknown date, the patient felt sick to his stomach, had severe abdominal pain and was not able to keep anything down.The patient also had nausea and vomiting.In the first few days, the patient had no problem and then later the patient was unable to have a bowel movement anymore and later something started building up and became painful and received laxatives as treatment.The patient spoke to a provider at ro and was advised to reduce dose to 1 capsule instead of 3 (pt: off label use).On an unknown date (two days after reducing dose), the patient was unable to eat anything and subsequently discontinued taking plenity on (b)(6) 2022.On (b)(6) 2022, the patient was admitted to emergency room and the patient attendant reported that patient was diagnosed with intestinal obstruction (pt: intestinal obstruction) and a part of bowel was ruptured (pt: intestinal perforation).Patient underwent an emergency surgery along with an ileostomy.On (b)(6) 2022, the patient¿s surgery was completed and events were resolving as the patient still had pain.In addition to surgery, the patient received pain medication and anti-nausea medication at the hospital for symptoms.This case was assessed as serious due to the life threatening nature of the events intestinal obstruction and perforation and also because patient was hospitalized and required surgical intervention.Action taken: patient discontinued plenity due to events (intestinal obstruction and gastrointestinal perforation).Outcome of the events intestinal obstruction and gastrointestinal perforation were resolving.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a (b)(6) male patient who reported intestinal obstruction and gastrointestinal perforation approximately 2 weeks following initiation of therapy with plenity for weight loss.Patient reported experiencing nausea, vomiting and abdominal pain since the day he started plenity.After a few days he reported constipation, for which his physician advised to reduce the dose to 1 capsule (pt: off label use) and additionally took laxative.However, his symptoms persisted and was taken to er.He reported to be diagnosed with intestinal obstruction and perforation for which he underwent emergency surgery followed by ileostomy.Medical history and concomitant medications were not significant.This case was assessed as serious due to the life threatening nature of the events and hospitalization requiring surgical intervention.Based on the reasonable temporal relationship and spontaneous nature of the report, causality is assessed as possible.More information regarding hospitalization and investigations 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: 13857415
• MDR Text Key: 293154522
• Report Number: 3012121187-2022-00029
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG