MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION COLD SPRINGS POISE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number MODERATE LONG

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

Patient Problems Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Rash (2033); Scar Tissue (2060); Sepsis (2067); Vomiting (2144)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) and quality records were reviewed.These documents demonstrate that procedures were correctly followed.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

The consumer stated that 10 minutes into wearing the pads, she developed a red, burning irritation with puss pockets in her vaginal area.She stopped wearing the pads the same day and the irritation eventually resolved.She then wore the pads for one hour three days later and the same irritation returned along with a large lump in her left labia.Two days after that, the lump had dark, odorous drainage and became very hard.She also had nausea, vomiting and fever.Consumer went to the emergency room on (b)(6) 2018 where the lump was assessed and was diagnosed with severe sepsis related to the infected lump.The lump was surgically removed.She was then admitted to the intensive care unit at the hospital where she received wound vac treatment, iv antibiotics and hydration for six nights (discharged (b)(6) 2018).She has been receiving outpatient wound care therapy three times a week since (b)(6) 2018.We followed up with consumer on (b)(6) 2018.She was not feeling well and was on pain medication.She had a doctor visit scheduled for (b)(6) 2018 for an x-ray to determine if infection has returned.We have been unable to contact the consumer for more information.No further information is available at this time.

Manufacturer Narrative

New information: additional information from follow up with consumer.Follow-up 2.Additional narrative: a visual inspection of 11 companion samples did not observe any product defects or abnormalities.

Event Description

Consumer reported during follow up that the wound has completely healed.She is experiencing pain in her back, hip and leg.She stated that her neurologist said the cause of pain was due to pinched nerves.She relayed that her neurologist performed a pelvic mri, which showed presence of tarlov cysts and that these were not likely be the cause of pinched nerves.She insists that the most likely cause of the pinched nerves is scar tissue from her surgical site.According to the consumer, a spinal mri should determine if the scar tissue is causing the pinched nerve.No additional information is available at this time.

Manufacturer Narrative

Updates: additional information added from follow up with consumer.Update: patient code - remove (b)(4) due to medical records add'l information: medical assessor summary;pre-existing conditions; patient code.Add'l narrative: the consumer preciously reported a diagnosis of sepsis.Our medical assessor reviewed medical records provided by consumer.The records did not indicate a diagnosis of sepsis.(b)(4).

Event Description

During follow up with consumer, she stated she underwent a ct scan of her back due to back pain and inflammation.Her doctor stated these were likely due to surgical site healing.Doctor also stated surgical site was healing as expected.No additional information is available at this time.

• Brand Name: POISE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer Contact: marian vargas ; 2100 winchester road; neenah, WI 54956 ; 9207215889
• MDR Report Key: 7388201
• MDR Text Key: 104069296
• Report Number: 2184163-2018-00001
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MODERATE LONG
• Device Lot Number: LF729322X0234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR