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

Model Number SIZE 2

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Urinary Tract Infection (2120)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the reported issue.

Event Description

Daughter reported on behalf of her mother that she put a pessary in but the string was not there so she put another pessary in thinking the previous one was removed.She then began experiencing bleeding and an odor and went to her doctor.Doctor tested urine and found blood and elevated wbc in urine, cipro was prescribed for 10 days.Urine was checked again 10 days later and the blood was gone but cipro was prescribed again just in case the infection was not cleared up.She completed her second round of cipro and was feeling fine.She then felt achy, bloated, feverish and began to experience back pain so was given a third round of cipro.She felt better with the antibiotics and stopped using the pessary.The antibiotics helped and she was feeling fine but her back pain continued and she took a lot of ibuprofen.She began spotting and had heavy vaginal bleeding so went back to the family care clinic.The clinic did an abdominal ultrasound of her bladder and ordered another urine analysis.The ultrasound looked normal and the ua showed blood in her urine again.Due to vaginal bleeding, an intravaginal ultrasound was done which found a mass near her cervix that looked like endometrial urterine cancer.She had an mri done and the mri showed a plastic foreign object near her cervix in the vaginal wall.She then had an appointment with an obgyn specialist.The pessary was the foreign object that the obgyn removed and there was no string.She does not have cancer and was back on antibiotics, doxycycline 100mg, twice a day.The last day of taking the oral doxycycline she was feeling much better.Her back was no longer hurting and her symptoms resolved.She began feeling better about three days after the pessary was removed.She was now experiencing an itchy rash in pubic area, knee pain, and high blood pressure.

• 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: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8937796
• MDR Text Key: 156733966
• Report Number: 3011109575-2019-01463
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998467
• UDI-Public: 00036000998467
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 08/27/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SIZE 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/27/2019
• 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): Other
• Patient Age: 75 YR