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

Device Problem Output Problem (3005)

Patient Problem Hematemesis (4478)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Patient text us after we reached out for pay auth.And said "no, she didn't want the refill and that she just got out of the hospital after starting the med.She was throwing up blood.Do not ever charge my card again i'm thinking about legal proceedings." i called the patient to discuss the situation.She told me that she had only been on the plenity for a day or two when she threw up a large amount of blood in the toilet.Her husband rushed her to the hospital where she was kept overnight.She had a procedure done the following morning to stop the bleeding by cauterization.Patient stated they found a sore in the lining of her intestines.I told the patient i was sorry this happened but was glad she was home recovering.She stated she still has a bandage from the iv.I asked her if she had started plenity this week then, she said no.It had been a few days.I asked her if it was started in (b)(6) 2021 and she stated yes.Patient has thrown away the remaining bottle.I told her i would report this to medwatch (without specific patient details) and also encouraged her to do so as well.She wanted to know how to do it online.I walked through (b)(6) "medwatch reporting" selecting the first one, then selecting report a problem.I told her if she has trouble finding it to give us a call back.Patient requested a refund, i told her i couldn't give the authorization but would ask.Management is aware of the patient's original message and that she has been contacted.Refund was approved and we are working on doing that.Fda safety report id# (b)(4).

• Brand Name: PLENITY
• Type of Device: INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT
• Manufacturer (Section D): GELESIS, INC.
• MDR Report Key: 13059502
• MDR Text Key: 282617388
• Report Number: MW5106174
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female