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 Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Complete blockage of large intestine [large intestinal obstruction], abdominal distention/abdomen was ready to burst [abdominal distension], constipated [constipation], vomiting [vomiting], dry heaves [retching], muscle mass in abdomen went away [muscle atrophy].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2022.A 62-year-old male patient (weight: 175 pounds) reported large intestinal obstruction, abdominal distension, constipation, vomiting, muscle wasting, and dry heaves while on plenity for weight management.The patient's baseline weight was 172 pounds; current condition included asthma, allergies included allergic to cats.He denied medical history and taking medications.On (b)(6) 2022, the patient started therapy with plenity (lot number: a21271; expiry date: 28-mar-2023) obtained from ro telehealth platform, at a dose of 3 capsules orally, 20-30 minutes prior to lunch and dinner, with a glass of water for weight management.On (b)(6) 2022, the patient stated that he started to feel weird, constipated (pt: constipation).He was never constipated before until he started plenity.On (b)(6) 2022, the patient discontinued the plenity.On (b)(6) 2022, he had dry heaves (pt: retching) and vomiting (pt: vomiting).He was treated with pepto bismol on the (b)(6) of (b)(6).On (b)(6) 2022, the patient went to the emergency room (er).The patient reported experiencing abdominal distention (pt: abdominal distension), "his abdomen was ready to burst", and "there was a complete blockage of his lower intestine" (pt: large intestinal obstruction).A computerized tomography (ct) scan was performed, and the patient was sent to a larger hospital.He had emergency surgery and now with colostomy bag.The patient reported that "the surgery saved my life".The patient had an ileostomy and colostomy placed.He stated that his abdomen was full of scars, and he was in a lot of pain and the pain level was high, and he was placed on norco after the surgery.Now he stated that his pain was 3 out of 10, and he no longer needed norco.On (b)(6) 2022, the patient had surgery to reverse the colonoscopy.He stated that he still had wounds and scars on his abdomen.His ileostomy will be reversed in about a month, and he stated that he had to spend a day or so in the hospital to see a plastic surgeon.The muscle mass in his abdomen went away (pt: muscle atrophy).Action taken: plenity was discontinued due to the events constipation, retching, vomiting, abdominal distension, large intestinal obstruction and muscle atrophy.The outcome of the events constipation, retching, vomiting was resolved; abdominal distension and large intestinal obstruction were resolved with sequelae and muscle atrophy was not resolved.It was reported that other factors might be associated with the events.This case is assessed as serious given the need for hospitalization and intervention (emergency surgery) required for the events abdominal distension and large intestinal obstruction.This case was not verified by a healthcare professional.Company comment: this spontaneous report refers to a 62-year-old male patient who reported large intestinal obstruction, abdominal distension, constipation, vomiting, muscle atrophy, and retching while on plenity for weight management.Current conditions included asthma and allergy to cats.The patient developed constipation 5 days after starting plenity and was prescribed pepto bismol; and after two days plenity was discontinued.The next day, patient developed vomiting and dry heaves and the subsequent day visited er with abdominal distension and complete lower intestinal blockage.The patient then underwent abdominal surgery (colostomy and ileostomy) on the same day.Approximately after five and a half months, patient had a reversal surgery.This case is assessed as serious given the need for hospitalization and intervention (emergency surgery) required for the events abdominal distension and large intestinal obstruction.Based on the reasonable temporal relationship, and spontaneous nature of the report, causality is assessed as possible for all the events.

Event Description

Complete blockage of large intestine [large intestinal obstruction].Abdominal distention/abdomen was ready to burst [abdominal distension].Constipated [constipation].Vomiting [vomiting].Dry heaves [retching].Muscle mass in abdomen went away [muscle atrophy].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 16-sep-2022.A 62-year-old male patient (weight: 175 pounds) reported large intestinal obstruction, abdominal distension, constipation, vomiting, muscle wasting, and dry heaves while on plenity for weight management.The patient's baseline weight was 172 pounds; current condition included asthma, allergies included allergic to cats.He denied medical history and taking medications.On (b)(6) 2022, the patient started therapy with plenity (lot number: a21271; expiry date: 28-mar-2023) obtained from ro telehealth platform, at a dose of 3 capsules orally, 20-30 minutes prior to lunch and dinner, with a glass of water for weight management.On (b)(6) 2022, the patient stated that he started to feel weird, constipated (pt: constipation).He was never constipated before until he started plenity.On (b)(6) 2022, the patient discontinued the plenity.On (b)(6) 2022, he had dry heaves (pt: retching) and vomiting (pt: vomiting).He was treated with pepto bismol on the 5th or 6th of march.The patient reported that retching did not last long and no treatment was received.On (b)(6) 2022, the patient went to the emergency room (er).The patient reported experiencing abdominal distention (pt: abdominal distension), "his abdomen was ready to burst", and "there was a complete blockage of his lower intestine" (pt: large intestinal obstruction).A computerized tomography (ct) scan was performed, and the patient was sent to a larger hospital.He had emergency surgery and now with colostomy bag.The patient reported that "the surgery saved my life".The patient had an ileostomy and colostomy placed.He stated that his abdomen was full of scars, and he was in a lot of pain and the pain level was high, and he was placed on norco after the surgery.Now he stated that his pain was 3 out of 10, and he no longer needed norco.On the same day of the surgery all the symptoms constipation, retching, vomiting, abdominal distension and large intestinal obstruction had resolved.On (b)(6) 2022, the patient was discharged from hospital and had underwent 3 ct scans of abdomen during hospitalization which did not show the reason for the obstruction.It was reported that the underlying cause for obstruction was unknown on (b)(6) 2022, the patient had surgery to reverse the colostomy and was hospitalized for 5 days.He stated that he still had wounds and scars on his abdomen.His ileostomy will be reversed in about a month, and he stated that he had to spend a day or so in the hospital to see a plastic surgeon.The muscle mass in his abdomen went away (pt: muscle atrophy).The patient experienced muscle atrophy as he was hospitalized for 15 days.Action taken: plenity was discontinued due to the events constipation, retching, vomiting, abdominal distension, large intestinal obstruction and muscle atrophy.The outcome of the events constipation, retching, vomiting was resolved; abdominal distension and large intestinal obstruction were resolved with sequelae and muscle atrophy was not resolved.It was reported that other factors might be associated with the events.This case is assessed as serious given the need for hospitalization and intervention (emergency surgery) required for the events abdominal distension and large intestinal obstruction.This case was not verified by a healthcare professional.Follow up information received on 12-oct-2022 included: stop date of the events constipation, retching, vomiting, abdominal distension and large intestinal obstruction; information regarding muscle atrophy; additional ct scans details; discharge date, colostomy reversal surgery related information, confirmation regarding underlying cause of obstruction was unknown and information regarding no treatment received for the event retching were updated.Narrative amended accordingly.Company comment: this spontaneous report refers to a 62-year-old male patient who reported large intestinal obstruction, abdominal distension, constipation, vomiting, retching and muscle atrophy while on plenity for weight management.Current conditions included asthma and allergy to cats.The patient developed constipation after 5 days of starting plenity and was prescribed pepto bismol; and after two days plenity was discontinued.The next day, patient developed vomiting and dry heaves and the subsequent day visited er with abdominal distension and complete lower intestinal blockage.The patient then underwent abdominal surgery (colostomy and ileostomy) on the same day and was discharged from the hospital after 15 days.The patient also experienced muscle atrophy due to the 15-day hospitalization.Approximately after five and a half months, patient had a surgery to reverse the colostomy and was again hospitalized for 5 days.Plenity was discontinued and the events constipation, retching, vomiting was resolved; and abdominal distension and large intestinal obstruction were resolved with sequelae.This case is assessed as serious given the need for hospitalization and intervention (emergency surgery) required for the events abdominal distension and large intestinal obstruction.Based on the reasonable temporal relationship, and spontaneous nature of the report, causality is assessed as possible for all the events.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: 15578479
• MDR Text Key: 301552125
• Report Number: 3012121187-2022-01028
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: MC0420
• Device Lot Number: A21271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG