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

Model Number SIZE 1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.

Event Description

The consumer stated that she is a new user and developed a bladder infection after using the product less than two weeks.She initially thought it was a yeast infection and treated it with otc monistat.She then saw her pcp and was diagnosed with a kidney infection.She was treated with oral antibiotics for one week and the infection was completely resolved.

• Brand Name: POISE IMPRESSA
• 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, sonora 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, sonora 84094 ; MX 84094
• Manufacturer Contact: angie masaro ; 2100 winchester road; neenah, WI 54956 ; 9207215934
• MDR Report Key: 5883367
• MDR Text Key: 52338555
• Report Number: 3011109575-2016-00004
• Device Sequence Number: 1
• Product Code: HHW
• 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: Patient
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2017
• Device Model Number: SIZE 1
• Device Lot Number: NN521471D0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR