Plenity™ MC0420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10860517002631), received between Dec 9, 2020 and Dec 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2020Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 2020. A 54-YEAR-OLD FEMALE PATIENT OF WEIGHT 160 LBS EXPERIENCED ANAPHYLACTIC REACTION WHILE ON PLENITY FOR OBESITY. THE PATIENT¿S MEDICAL HISTORY INCLUDED HYPERTENSION AND HOT FLASHES. THE PATIENT HAD NO KNOWN FOOD ALLERGIES. THE PATIENT¿S CONCOMITANT MEDICATIONS INCLUDED IRBESARTAN (12.5 MG DAILY) FOR HYPERTENSION. THE PATIENT'S CO-SUSPECT MEDICATIONS INCLUDED CELEXA (CITALOPRAM HYDROBROMIDE) (20MG, DAILY, MORNING, FOR ABOUT A WEEK) FOR HOT FLASHES. ON (B)(6) 2020, 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 (B)(6) 2021. ON AN UNSPECIFIED DATE (3-4 DAYS PRIOR TO HOSPITAL DISCHARGE) THE PATIENT EXPERIENCED THE SYMPTOMS OF ITCHY BURNING RASH ON THE HEAD AND FLU-LIKE SYMPTOMS ON NEXT DAY. ON AN UNKNOWN DATE, THE PATIENT TOOK CELEXA IN THE MORNING, AND ON THE SAME DAY, THE PATIENT WENT TO THE EMERGENC

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 10993293 ↗
• InjuryDec 9, 2020Improper or Incorrect Procedure or Method

  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 ALL

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 10975537 ↗