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	Product Quality Problem (1506)
Health Effect - Clinical Codes	Abrasion (1689); Genital Bleeding (4507)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.A supplemental follow-up report will be submitted upon completion.
Event or Problem Description
Consumer reported that the applicator petals of an unspecified number of pessaries were partially open and during insertion she was pinched and noticed blood and a cut.She has improved.She did not seek medical attention and she did not report any serious adverse health effects.
Additional Manufacturer Narrative
Samples received from consumer were consistent with the reported complaint.The investigation was completed.The root cause of the reported event was determined to be related to process controls during manufacturing at the petal forming station.At this time, the affected product has been discontinued, and no further manufacturing will be undertaken.If production is resumed in the future, improved process controls will be implemented at the petal forming station prior to manufacturing.Additional information: g3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: if follow-up, what type? h6: investigation findings, investigation conclusion.H11: manufacturer narrative.

• 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: 23464875
• Report Number: 3011109575-2025-00082
• Device Sequence Number: 9949998
• Product Code: HHW
• UDI-Device Identifier: 00036000496185
• UDI-Public: (01)00036000496185(17)290401(10)NN520571A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 11/25/2025

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
• Device Lot Number: NN520571A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 Sex: Female