MAUDE Adverse Event Report: FARMA-DERMA S.R.L. REVAREE VAGINAL SUPPOSITORY; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Urinary Tract Infection (2120); Kidney Infection (4502)

Event Date 11/24/2022

Event Type  Injury  

Event Description

A 59-year-old female reported that she received treatment for 10 hrs in emergency room after developing "an infection, a urinary tract infection, a kidney infection and near-sepsis", 4 days after restarting the vaginal suppository product revaree.She had taken the product for a few months without incident, stopped and then restarted.Four days after restarting, she developed worsening pelvic discomfort and fever of 103.5 f.She went to the emergency room, when she was diagnosed with a uti, kidney infection and vaginal infection.She had a negative ct scan and ultrasound and had bloodwork performed.She received "2 bags of iv fluids" and a dose of iv antibiotics.She was told that she had "near sepsis' and if she has waited longer.Her described the event, or problem condition may have worsened.Although she had taken the product for 2 months, with some improvement, she has decided to permanently discontinue the product.She was sent home with a prescription for 2 weeks of doxycycline.Discussion: because the consumer was on the product at the time of the event.It is impossible to rule out a possible contribution.Utls, typically non-serious, have been reported in women taking the product.In some women.The product may be irritative, especially in the setting of atrophic vaginal tissue associated with menopause.Although the customer was not hospitalized.The intensity of therapy and mention that she was "near sepsis" elevates this case to an important medical event.In addition, she noted that the hospital was reported to be full.The manufacturer will continue to carefully monitor the safety of its products.(b)(4).

• Brand Name: REVAREE VAGINAL SUPPOSITORY
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): FARMA-DERMA S.R.L.
• MDR Report Key: 16157370
• MDR Text Key: 307488004
• Report Number: MW5114312
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOXYCYCLINE; IV ANTIBIOTICS; IV FLUIDS
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG