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

Model Number	SIZE 2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon review of the dhr, the lot met all acceptance criteria at the time of release.The final investigation is pending sample return and evaluation.
Event or Problem Description
Consumer reported upon removal the string pulled out of the bladder support leaving the device inside her vaginal cavity.She was able to manually remove the device and did not seek medical attention.She did not experience any adverse health effects.
Additional Manufacturer Narrative
H10 device evaluation: a visual inspection of 11 companion samples did not observe any product defects or abnormalities.

• 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: 11318063
• Report Number: 3011109575-2021-00037
• Device Sequence Number: 2439926
• Product Code: HHW
• UDI-Device Identifier: 00036000496192
• UDI-Public: 036000496192
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/11/2021

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 2
• Device Lot Number: NN921871A01062023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR