MAUDE Adverse Event Report: RINOVUM SUBSIDIARY 2, LLC REVIVE REUSABLE BLADDER SUPPORT; VAGINAL PESSARY

Model Number	0025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Genital Bleeding (4507); Pelvic Pain (4865); Perineal injury (4898)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown whether or not the device caused the issue; however the device was being used during the time the event occurred.It seems unlikely that a vaginal device would lead to a perineal hematoma since the device is not intended to come into contact with the perianal or anal space.The event required medical intervention.Therefore, we are reporting in compliance with mdr requirements.Risk assessment was determined not to be impacted, but this ae will be trended.This is an isolated event that appears at this time to be an anomaly.
Event or Problem Description
Patient went to the emergency room due to experiencing bleeding and pain.She was diagnosed wtih a perineum hematoma, which the physicican contributed to the bleeding that i experienced from wearing the device 2 weeks ago.The patient indicated that she also expereienced a urinary tract infection which occured after the first couple of uses.The last time she used the product was 2 weeks prior to the incident.·.

• Brand Name: REVIVE REUSABLE BLADDER SUPPORT
• Common Device Name: VAGINAL PESSARY
• Manufacturer (Section D): RINOVUM SUBSIDIARY 2, LLC; 4923 simmons circle; export; pa 15632
• Manufacturer Contact: niki spaniel ; 4923 simmons circle; export,, PA 15632 ; 4122007996
• MDR Report Key: 21146119
• Report Number: 3015417614-2025-00001
• Device Sequence Number: 12846778
• Product Code: HHW
• UDI-Device Identifier: 00854389008009
• UDI-Public: 00854389008009
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183468
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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 Model Number: 0025
• Device Catalogue Number: N/A
• Device Lot Number: 109474509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White