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

Model Number	SIZE 3
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Intermenstrual Bleeding (2665)
Date of Event	02/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
Event or Problem Description
Consumer reported upon removal the string pulled out of a bladder support leaving the device inside her vaginal cavity.She attempted to manually remove the bladder support and experienced vaginal bleeding.She was unable to remove the device on her own and the next morning, after speaking with her insurance company and her doctor, she was referred to a gynecologist.The gynecologist removed the bladder support and cleaned the area with iodine.Consumer was prescribed doxycycline as a preventive.She experienced pain and discomfort in her belly button area after the bladder support was removed.The bleeding, pain and discomfort resolved a few days later and she did not receive any additional medical treatment.

• 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
• MDR Report Key: 11590253
• Report Number: 3011109575-2021-00093
• Device Sequence Number: 14367065
• Product Code: HHW
• UDI-Device Identifier: 00036000496215
• UDI-Public: 036000496215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/30/2021

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: SIZE 3
• Device Lot Number: NN834971C
• 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: 03/03/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR