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

Model Number	SIZE 1
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/05/2020
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 she went to remove the pessary and found the string detached in her underwear and the pessary was still inside her vaginal cavity.She attempted to manually remove the pessary and scratched herself which caused some spotting and vaginal burning sensation.She was unable to remove the pessary on her own and went to the er.The er doctor removed the pessary.She did not experience any adverse health effects and did not receive any additional medical treatment.She reported the spotting and burning sensation resolved.
Additional Manufacturer Narrative
New information: b5: three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.
Event or Problem Description
Three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.

• 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: 10692935
• Report Number: 3011109575-2020-01771
• Device Sequence Number: 3933438
• Product Code: HHW
• UDI-Device Identifier: 00036000496185
• UDI-Public: 036000496185
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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 1
• Device Lot Number: NN932371A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR