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

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Pain (1994); Urinary Frequency (2275)

Event Date 06/01/2017

Event Type  Injury  

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 records can be performed.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, all complaints are also monitored for trending on a monthly cadence.Investigation is currently in progress.A follow up report will be submitted once results are available.

Event Description

On (b)(6) 2017, the consumer stated she used an unknown size of poise impressa bladder support product and removed it shortly after insertion due to discomfort.The consumer experienced vaginal pain and an increase in urinary leakage.Two to three months later, the consumer sought medical attention and a 5-6 cm cylindrical smooth plastic object was removed.She experienced a small amount of vaginal bleeding, increased urinary leakage and was diagnosed with urethrovaginal fistula.On the wellness check on (b)(6) 2017, the consumer stated that she was doing fine and going back to her urologist on (b)(6) 2017.On wellness check on (b)(6) 2017, the consumer stated she is scheduled to have the urethovaginal fistula repair on (b)(6) 2017.

• 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; malquiladoras #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; malquiladoras #87; nuevo nogales, sonora 84094 ; MX 84094
• Manufacturer Contact: marian vargas ; 2100 winchester rd; neenah, WI 54956 ; 9207215889
• MDR Report Key: 6948066
• MDR Text Key: 89369357
• Report Number: 3011109575-2017-00076
• Device Sequence Number: 1
• Product Code: HHW
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR