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

Model Number SIZE 1

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Blood Loss (2597)

Event Date 04/14/2016

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; therefore the complaint could not be confirmed.Complaint sample was not returned therefore a product evaluation could not be performed.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

On initial contact with the consumer, she stated that she experienced pain and light bleeding upon using the product for the first time.She removed the bladder support after 6 hours and discontinued using the product.One week later, the consumer reported that she had developed a kidney infection and was prescribed antibiotics by her physician.

• 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 (NUEVO NOGALES; calzada industrial; de las maquiladoras # 87; nuevo nogales, nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: angie masaro ; 2100 winchester rd.; neenah, WI 54956 ; 9207215934
• MDR Report Key: 5670055
• MDR Text Key: 45613619
• Report Number: 3011109575-2016-00002
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SIZE 1
• Device Lot Number: NN532271A1256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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: 69 YR