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 Break (1069)

Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

The consumer reported the string pulled out in two pieces leaving the pessary inside.She was unable to remove the pessary and had to visit a doctor for assistance.The doctor removed the pessary and she experienced pain, vaginal tenderness, bleeding, discomfort, and increased urinary leakage.Her pain, tenderness, and bleeding has subsided.Multiple attempts have been made to obtain further information, 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: 9601065
• MDR Text Key: 178550109
• Report Number: 3011109575-2020-00214
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998474
• UDI-Public: 00036000998474
• Combination Product (y/n): N
• PMA/PMN Number: K131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/17/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: SIZE 3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR