MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V POISE IMPRESSA : PESSARY, VAGINAL : HHW

Model Number	PESSARY
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
With no means to determine the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.The udi device identifier was determined utilizing the upc since the upc was the only information provided by the consumer.The expiration date and lot number were not provided by the consumer.The consumer did not have the package or individual product wrapper.
Event or Problem Description
Consumer reported upon removal of a pessary, the string separated from the pessary.She was not able to manually remove the pessary from her vaginal cavity so approximately one hour later she had it removed by a doctor.She experienced minor intermittent bleeding.She did not report allegations of a serious adverse event or harm.Multiple attempts have been made to obtain further information regarding the consumer¿s use of the product and outcome; however, no further information has been received.

• Brand Name: POISE IMPRESSA : PESSARY, VAGINAL : HHW
• Common Device Name: PESSARY, VAGINAL
• Manufacturer (Section D): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer (Section G): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 21044543
• Report Number: 3011109575-2024-00112
• Device Sequence Number: 11610669
• Product Code: HHW
• UDI-Device Identifier: 00036000496192
• UDI-Public: (01)00036000496192
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PESSARY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female