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 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: (b)(4).

Event Description

It was reported the patient was ¿admitted with an unstageable pressure injury.¿ it was further reported ¿patient with prerenal 2/2 severe infection, gi bleed.¿ 10hgb 7.0, up from 6.1 with transfusion.Gi bleed continues.Patient with a full thickness wound bed to the sacrococcygeal area.Fecal management system (fms) remains, also foley in place.Unstageable to the sacral coccyx - dakin's moist gauze over wound bed then cover with dry abd pad and secure.Fms remains in place.Minimal leakage of stool noted.Patient continues with high output gi bleed/loose stool >500ml in last 24 hours.Anus assessed and found to have a full thickness ulceration that extends out to the perineum secondary to tubing.The wound with stained adipose tissue from fecal leakage.Ulceration presents as a device related stage 3 hospital acquired pressure injury.The fms was left in place due to high output diarrhea and the presence of a full thickness wound bed to the sacrococcygeal area.At this time the benefit outweighs the risk.Per md note, on 3/1, patient's blood pressure dropped to 60s systolic, with active bleeding noted from peripheral iv's, rectal tube, foley.It was noted ¿patient made comfort care on 3/1.Stopped comfort care on 3/2 per wife's request - wanting just antibiotics and transfusions to be restarted for a couple of days, but nothing that will "hurt" patient.Discussed extensively with wife and daughter re: poor prognosis and family continues to want to restart transfusion and antibiotic for a couple days and reassess after 2 days.Family does not want to do anything invasive.¿.

• 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: 14514999
• MDR Text Key: 292727220
• Report Number: 1049092-2022-00290
• 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 Sex: Male