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

Model Number SIZE 3

Device Problem Difficult to Remove (1528)

Patient Problems Abdominal Pain (1685); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/10/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 280478047
• Report Number: 3011109575-2021-00639
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000496208
• UDI-Public: 036000496208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female