MAUDE Adverse Event Report: KIMBERLY CLARK POISE IMPRESSA

Model Number 3

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

Patient Problems Incontinence (1928); Renal Failure (2041); Sepsis (2067); Heart Failure (2206); Respiratory Failure (2484)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Started using poise impressa #3 2015, after 2 days of use (8 hour per insert) i became ill and was hospitalized for ui and septic, recovery was in 10 days in hospital stay.Reused the product poise in early 2016, again, after 3 days contracted another ui and was hospitalized for 14 days.I regarded that the 2 past infections were somehow my fault.I again used the poise product in (b)(6) 2016 for 3 days as per manufacturer's instructions in the box.Again was hospitalized for ui infection that was also diagnosed as sepsis shock.Placed in icu on full life support in a medical induced coma.Kidney, lung, heart failure.On duty head icu nurse asked my husband if i could be taken off life support because with most organs failing the outlook for survival was near zero.Subsequently all drugs were stopped and i was allowed to wake.The head icu nurse questioned me on staying on life support or being let go.I opted to be on life support, a total of 30 days.Feeling somewhat better i was moved to another hospital for intensive respiratory treatment as i now have a tracheostomy.After a month or so was moved to a health care facility.While still not at 100 percent of health to date and still have a negative growth of 1.1 cm in my heart valve that will require open heart surgery in the near future after full health is gained.I was cautioned by my cardiologist not to exert myself that could cause the growth breaking off and causing death.

• Brand Name: POISE IMPRESSA
• Type of Device: POISE IMPRESSA
• Manufacturer (Section D): KIMBERLY CLARK
• MDR Report Key: 6890060
• MDR Text Key: 87387898
• Report Number: MW5072366
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 68 YR
• Patient Weight: 100