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 Material Separation (1562)

Patient Problems Pain (1994); Discomfort (2330); Intermenstrual Bleeding (2665)

Event Date 02/28/2021

Event Type  malfunction  

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 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
• 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: 11590253
• MDR Text Key: 243099572
• Report Number: 3011109575-2021-00093
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000496215
• UDI-Public: 036000496215
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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: NN834971C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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: 70 YR