MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. BREATHTEK UBT

Model Number	01
Health Effect - Clinical Code	Constipation (3274)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported complications after drinking pranactin-citric solution.Patient said she had "bubble guts" for 20 minutes after drinking solution and then did not product stool for 4 days after.Patient reported complications after drinking pranactin-citric solution.Patient said she had "bubble guts" for 20 minutes after drinking solution and then did not product stool for 4 days after.The product labeling includes a precautionary statement regarding that those who are hypersensitive to mannitol should avoid taking the drug solution.Hypersensitivity is a known reaction that is also identified within the labelings post-marketing experiences section.

• Brand Name: BREATHTEK UBT
• Common Device Name: BREATHTEK UBT
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 6471 river hills dr.; cincinnati OH 45244
• Manufacturer (Section G): MERIDIAN BIOSCIENCE INC.; 6471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: megan berling ; 6471 river hills dr.; cincinnati, OH 45244 ; 5132713700
• MDR Report Key: 13930298
• Report Number: 1524213-2022-00003
• Device Sequence Number: 20410592
• Product Code: OZA
• UDI-Device Identifier: 00840733101434
• UDI-Public: 00840733101434
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P100025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2024
• Device Model Number: 01
• Device Catalogue Number: 8209
• Device Lot Number: 453K05L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White