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	Difficult to Remove (1528)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Records demonstrate that quality system procedures were correctly followed and the finished product met all quality release criteria and specifications were within allowable limits prior to release.
Event or Problem Description
Consumer reported she had pain with the insertion of a bladder support and attempted to remove it right away but could not find the string to remove it.The bladder support remained inside her vaginal cavity for two days.She stated she had been trying to remove it herself and could feel the bladder support inside but could not get a grip on it to remove it.She called and spoke with a nurse who told her she could not do anything for her without a doctor's order.During the last contact with the consumer, she stated she was getting ready to go to the er to have the impressa removed.She reported she was experiencing abdominal pain and cramping in her back.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: 12771475
• Report Number: 3011109575-2021-00639
• Device Sequence Number: 14239205
• Product Code: HHW
• UDI-Device Identifier: 00036000496208
• UDI-Public: 036000496208
• Combination Product (Y/N): N
• 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): 11/08/2021

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: NN033271A
• 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: 10/12/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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: 74 YR
• Patient Sex: Female