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 2

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

Device history record could not be reviewed as lot code was not provided by the consumer.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned product for evaluation at the time of this report.

Event Description

Consumer stated that she developed a stabbing pain in her lower abdomen after using the third pessary.She removed the support at that time but over the next 2 days the pain increased.She went to urgent care on sunday where the kidney infection diagnosis was provided.Consumer reported after 2 rounds of oral antibiotics her infection is resolved.

• 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 # 14; parque industrial nuevo nogales; nogales, c.p. 84094 ; MX 84094
• Manufacturer Contact: jean nielsen ; 2100 winchester rd.; neenah, WI 54956 ; 9207216517
• MDR Report Key: 5359856
• MDR Text Key: 35656704
• Report Number: 3011109575-2016-00001
• 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: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SIZE 2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/12/2016
• 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: 50 YR