MAUDE Adverse Event Report: RO / GELESIS INC. PLENITY; INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT

Device Problem Use of Device Problem (1670)

Patient Problem Abdominal Pain (1685)

Event Date 03/22/2023

Event Type  Injury  

Event Description

Advise from my doctor about taking plenity (company calls ro) pills for weight loss, i went through the interview process to get them, and i'm sorry i did, i ended up in the hospital for 3 days with tubes sticking out of nose into my stomach to get my small intestine to unblock.Severe abdominal pain like i was being crushed.This medication or supplement is very dangerous and they should be stopped from prescribing and profiting from it.

• Brand Name: PLENITY
• Type of Device: INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT
• Manufacturer (Section D): RO / GELESIS INC.
• MDR Report Key: 16690495
• MDR Text Key: 312893707
• Report Number: MW5116393
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; LISINOPRIL; PANTOPRAZOLE
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White