MAUDE Adverse Event Report: CONVATEC INC L3C3950 - FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 01/23/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

It was reported a stage 3 hapi (hospital-acquired pressure injury) to the perianal area due to the flexiseal.Patient is a (b)(6) female, day 30 of admission.Per consult, a "skin tear was present in anal area, rectal tube was discontinued today at 0400am with redness and skin discoloration.The flexiseal was placed on (b)(6) and removed on (b)(6).Patient was assessed by primary nurse and patient rolled to side.Episode of fecal incontinence noted, and hygiene provided.Perianal skin assessed and patient was noted with full thickness tissue injury at 12 o'clock that extends into the perineum.Ulceration approximately 1.5 x 1.5 cms with slough to 50% of the wound bed.Staff to apply triad wound paste to area to protect from stool and promote autolytic debridement of non-viable tissue." the patient was initially admitted to the icu unit via the emergency department with cough, nausea, vomiting, diarrhea x 1-week, elevated blood sugar and lethargy x 2 days.Patient states she is non-compliant with her medications and cpap.Principal problem identified as: acute respiratory failure, coronavirus covid-19 pneumonia, severe sepsis w acute organ dysfunction, dm 2 w ketoacidosis, and dm 2 w dyslipidemia.Patient was intubated and on vent ¿ covid 19 pna.No lot number reported within complaint email, no photos received depicting reported complaint issue.

• Brand Name: L3C3950 - FLEXI-SEAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14514683
• MDR Text Key: 292724198
• Report Number: 1049092-2022-00289
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2022

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: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72
• Patient Sex: Female