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 (b)(6) male with no significant past medical history who was brought in by paramedics after being altered at home.Per parents, patient woke parents up reporting severe headache.Parents noted that he was slurring his speech.Patient then had a seizure and collapsed.On medics arrival, patient was with shallow breathing, oxygen saturation dropped to 80%.Parents deny use of drugs, antiplatelet or anticoagulants.In emergency department, patient was found to have right frontal, temporal, parietal iph, with extensive intraventricular hemorrhage, with acute sah.Patient was taken to or.Patient was admitted (b)(6) 2022, fms placed (b)(6) 2022 and removed (b)(6) 2022.During consult it was noted ¿wound noted at anal site with rectal tube in place.¿ patient is in critical condition, admitted to icu.Patient is on ventilator, pressors, eeg dc'd, evd remains and needed to be increased.S/p: right craniectomy for avm.Patient to go for peg tomorrow patient only able to be supine and turned to the left due to the right craniotomy.Los: 15gsw: 5.Patient resting in bed.Patient turned to his left side flexiseal in place, the area at 11 o'clock noted with an injury.Flexiseal discontinued and removed for assessment.There is a full thickness wound that erodes from the anus into the perineum.The wound bed with 50% tan fibrin, 50% pink and moist.Presents as a stage 3 pressure injury that is a hospital acquired device related hospital acquired pressure injury.

• 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: 14514316
• MDR Text Key: 292721221
• Report Number: 1049092-2022-00291
• 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

• Date FDA Received: 05/26/2022
• 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
• Date Manufacturer Received: 05/17/2022
• 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: 20
• Patient Sex: Male