MAUDE Adverse Event Report: GELESIS, INC. PLENITY; DELIVERY SYSTEM

Model Number MC0420

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Product is not retrievable.

Event Description

Anaphylaxis [anaphylactic reaction].3 capsules, po, 1 time daily [wrong technique in device usage process].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on 12-nov-2020.A (b)(6)-year-old female patient of weight (b)(6) lbs experienced anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported.The patient¿s concomitant medications included celexa (citalopram hydrobromide) (20mg daily), irbesartan (12.5 mg daily) for unknown indication.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (wrong technique in device usage process) for obesity.The lot number included p20114a and expiry date 23-oct-2021.On 10-nov-2020, it was reported that the patient went to emergency department due to severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction).The patient was treated with epinephrine and steroids (unspecified) and was admitted to intensive care unit (icu).It was reported that the patient was seen by the physician due to the concern of viral infection but was determined the event as allergic reaction.It was reported that the physician thought the allergic reaction was most likely due to celexa 20 mg/daily, which the patient daily administered along with the plenity at same time.The diagnostic tests were not carried out for the event.At the time of this report, therapy with the plenity was discontinued and outcome for the event (anaphylactic reaction) was resolved.The patient would be discharged on (b)(6) 2020 (reported as today).This case was verified by a healthcare professional.Company comment: this spontaneous report by a physician concerns a (b)(6)-year-old female weighing (b)(6) lbs who was diagnosed with anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported but included taking medications celexa (citalopram) (20mg daily), irbesartan (12.5 mg daily) for unknown indications.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (pt: wrong technique in device usage process) for obesity; around the same time, patient is reported to have started treatment with celexa (citalopram).After an unknown period since plenity and citalopram administration, patient presented to the emergency department with severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction) which was treated with epinephrine and steroids (unspecified).Patient was admitted in the intensive care unit (icu) where she was seen by an infectious disease physician for concerns of viral infection which was ruled out and a diagnosis of anaphylactic reaction was established.The physicians suspected that the allergic reaction was most likely due to celexa (citalopram) which the patient took concurrently with plenity.At the time of this report, therapy with the plenity was discontinued and the event (anaphylactic reaction) was resolved and patient was planned for a discharge on 12-nov-2020.The event anaphylactic reaction was assessed as serious as it required hospitalization.The case lacks details on medical history, dechallenge and rechallenge; nevertheless, due to the plausible temporal relationship, causality was assessed as possibly related to plenity.Nonetheless, celexa (citalopram) is a strong confounder in this case, in alignment with the hospital physician assessment and the fact that anaphylaxis has been observed during the post marketing evaluation of celexa (citalopram).

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section G): GELESIS, INC.
• Manufacturer Contact: 501 boylston street, suite 610; 2; boston, MA 02116
• MDR Report Key: 10975537
• MDR Text Key: 220464805
• Report Number: 3012121187-2020-00008
• Device Sequence Number: 1
• Product Code: QFQ
• UDI-Device Identifier: 00860517002641
• UDI-Public: 00860517002641
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2021
• Device Model Number: MC0420
• Device Lot Number: P20114A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: No
• 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: CELEXA (CELECOXIB),; IRBESARTAN AL (IRBESARTAN),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73