MAUDE Adverse Event Report: K-C AFC MANUFACTURING S. DE RL DE CV POISE IMPRESSA; PESSARY, VAGINAL

Model Number SIZE 3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 12/12/2016

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.The product involved in the complaint 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.Additional patient/ event information has been requested but was not received at the time of this report.It is unclear if the product caused or contributed to the event.Should additional information become available, a follow up report will be filed at that time.

Event Description

Husband called on behalf of his wife who was currently on life support in the icu with septic shock resulting from a uti.The husband stated his wife was using a pessary and sometimes used the product multiple times a day.In follow up calls with the husband he stated that his wife was transferred to a long term critical care facility where she is stable, alert, and has a tracheostomy.

Manufacturer Narrative

This mdr is a follow up that incudes sample evaluation and discussion of medical records.Additional investigation findings: medical records - follow up calls in january and february of 2017 with consumer's husband and medical records provided in january 2017 suggested that consumer has been making steady recovery.The medical records state that she was on supplemental oxygen; she could eat on her own; and verbally communicate.Her medical history included type 2 diabetes mellitus, hyperlipidemia, hypertension, hypothyroidism, obesity, obstructive sleep apnea syndrome, knee and hand replacement surgeries etc.It confirmed diagnosis of uti, acute renal failure and acute respiratory failure.In the medical record, no physicians indicated the impressa product being the cause of or contributed to the consumer's medical conditions.Sample evaluation - two companion samples of poise impressa size 3 were received.It is not known if these 2 companion samples are from the same box as was reported in the complaint.The visual examination did not observe any product defects or abnormalities.The microbiology results for the complaint sample lot code of returned samples showed that this lot passed all micro testing before commercial release.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Information below documents additional follow-up calls initiated by kimberly-clark with consumer's husband.On (b)(6) 2017 consumer's husband reported that his wife continued to improve slowly.His wife was to be discharged from the first facility on (b)(6) 2017 and transferred to a long-term care facility closer to their home to provide the specialized respiratory care needed which at that time was the most pressing issue.On (b)(6) 2017 consumer's husband stated his wife was still residing in a long-term care facility.She was making slow, but steady progress.On (b)(6) 2017 a follow up call was placed with consumer's husband.He stated that he was convinced impressa is the cause of his wife's prolonged medical issues.(this is different than previous conversation noted in initial mdr).He also said that she remains in a long care facility attempting to gain strength so that she can undergo open-heart surgery.She has a vegetative bacterial growth on her heart valves that requires intervention.Currently she is on supplemental oxygen but can eat on her own as well as verbally communicate.We asked if there were medical professionals who attributed her illness to impressa and he said there were.We asked for that supporting documentation.He stated he was considering legal action and would not commit to sending it to us.We asked if we could continue to follow up with him regarding his wife's health.To date we have not obtained additional information.

• Brand Name: POISE IMPRESSA
• Type of Device: PESSARY, VAGINAL
• Manufacturer (Section D): K-C AFC MANUFACTURING S. DE RL DE CV; calzada industrial; de las maquiladoras #87; nogales, cp 84094 ; MX 84094
• Manufacturer (Section G): K-C AFC MANUFACTURING S. DE RL DE CV; calzada industrial; de las maquiladoras #87; nogales, cp 84094 ; MX 84094
• Manufacturer Contact: jean nielsen ; 480 exchange ave; conway, AR 72032 ; 5013366325
• MDR Report Key: 6264685
• MDR Text Key: 65313785
• Report Number: 3011109575-2017-00003
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2017
• Device Model Number: SIZE 3
• Device Lot Number: NN531271D2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR