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

Model Number 418000

Device Problem Off-Label Use (1494)

Patient Problems Tissue Breakdown (2681); Gastrointestinal Hemorrhage (4476)

Event Date 01/04/2022

Event Type  Injury  

Event Description

It was reported that patient ((b)(6) white male) was admitted to the hospital upper and lower extremity weakness.He was found to have cardiac and thyroid issues.He was placed in the facility intensive care unit and the fecal collection device was placed, unknown indications for why device was placed.It was reported that the patient had "severe hemorrhoids.It is noted within the product instructions for use (ifu) that: "system should not be used on individuals who have hemorrhoids of significant size and/or symptoms".It was reported that "the staff was not aware of the contraindication and inserted the fms".On (b)(6) 2022 it was reported that the patient had "frank blood and blood clots" noted from rectum.The device was removed and the patient was noted to have "multiple areas of macerated denuded consistent with incontinence associated dermatitis", it was reported that the flexiseal was leaking, but extent of leakage not reported.It is also reported that the patient went to surgery and it is documented that the patient had "large rectal ulcer extending to about 15 cm with circumferential appearance and irregular margins.Heaped up erythematous surrounding mucosa was oozing on contact, bx taken to rule out malignancy.Deeper ulcerated regions seen extending to the anal verge with a visible vessel seen in an ulcerated region around 5cm from the anal verge.Epinephrine 1cc was injected into the surrounding tissue.Bipolar heat was applied once for 10s followed by coagrasper coagulation.There was still minimal oozing at the base and therefore two clips were applied.At the end of the procedure there was no bleeding after copious irrigation." patient was eventually discharged to a skilled nursing facility.It is unknown the amount of liquid that was instilled into the device balloon.The lot number of the product is also unknown.No photographs were received depicting the 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: 13566115
• MDR Text Key: 287417370
• Report Number: 1049092-2022-00064
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• 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: 34
• Patient Sex: Male
• Patient Race: White