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

Model Number 418000

Device Problem Off-Label Use (1494)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

E1: patient country: united kingdom.Affiliation: (b)(6) hospital (b)(6).Based on the available information, this event is deemed to be a reportable serious injury.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 8022978.

Event Description

It was reported "the patient used the item from (b)(6) 2023 to (b)(6) 2023 - on the (b)(6) 2023 the patient was reported to have an anal tear.The product was removed and a further bag inserted.The tear was reviewed by surgeons and they advised it would be likely the patient would need a stoma due to the tear, the patient passed away so unfortunately they could not assess whether the tear would heal." per additional information received, it was unclear if a rectal exam was performed prior to placement.It was further stated "we always put 45 mls in the balloon as specified by the manufacturer and the reason it went in was the patient had loose stools and her skin was vulnerable and breaking down.The cause of death on the death certificate was septicaemia and immunosuppression secondary to treatment for rheumatoid arthritis.".

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Manufacturing site: 8022978.

• Brand Name: FLEXI-SEAL SIGNAL
• 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: 17350480
• MDR Text Key: 319348546
• Report Number: 1049092-2023-00224
• 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: Foreign,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Lot Number: 22FM0409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2022
• 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