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

Model Number SIZE 3

Device Problem Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Fever (1858); Hematoma (1884); Laceration(s) (1946); Discomfort (2330); Blood Loss (2597)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Investigation findings: the device history record (dhr) did not show anomalies that may have caused or contributed to the reported issue.Records also demonstrate that quality system procedures were correctly followed.A lot assessment found no other similar or related complaints for the reported lot.Complaints which are serious in nature are reviewed on a weekly basis or for due cause to provide visibility and escalation.In addition, all complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

The consumer stated that her poise impressa sz 3 was inserted at the end of (b)(6) and she thought she had removed the product because there was no string found.On (b)(6) (3 weeks later) she experienced pain in her side and a lot of bleeding.The consumer went to her ob gyn and had the pessary removed.She was diagnosed with laceration of the vaginal wall.Three sutures were required to close the wound.She was placed on antibiotics for seven days and tylenol #3 for pain as needed.On (b)(6) she developed a slight fever and on (b)(6) the consumers bleeding returned.She went to the emergency room where she was told that a clot had formed around the sutures in her vaginal wall.No medications prescribed.Final follow-up with her ob gyn was on (b)(6) 2017 and was told vaginal wall was healing well.On (b)(6) wellness follow-up, consumer was no longer experiencing pain or bleeding.No further information is available at this time.

Manufacturer Narrative

Medical records were received on september 20, 2017.

• Brand Name: POISE IMPRESSA
• Type of Device: POISE IMPRESSA
• 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: marian vargas ; 2100 winchester road; neenah, WI 54956 ; 9207215889
• MDR Report Key: 6877501
• MDR Text Key: 86705826
• Report Number: 3011109575-2017-00066
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00036000998474
• UDI-Public: 00036000998474
• 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,Followup
• Report Date: 10/09/2017

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: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Model Number: SIZE 3
• Device Lot Number: NN707371A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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: 46 YR