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

Model Number 418000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.The event is deemed misuse.Per the product ifu, the device should only be filled to 45 ml.No lot number reported; therefore, unable to confirm vesta or fortune manufacturing site.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Mdr 1049092-2019-00244 / device 1 of 1.(b)(4).

Event Description

It was reported that a patient with a fecal management device had "bleeding" with the product.It was also reported that "normally 45 ml should be inserted into the balloon, but 100ml was inserted" and "seems to be the cause of bleeding".According to the report the patient lost " 2 liters per day on the first day, about 600 ml per day after the symptoms calm down".It is unknown how long the product was in use in the patient.It was questioned if the patient required any blood transfusions to replace the volume lost, the response was "the doctor followed the blood transfusion of the blood coagulant." it is unknown if the patient was on any anticoagulants at the time of usage.It is also unknown if a rectal exam was done prior to placing the device.It is noted that the patient was "originally hospitalized had severe diarrhea and confirmed the bleeding using this product".The patient was noted at time of complaint to be "stable".Lot information for the product is unknown.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 9414705
• MDR Text Key: 169814893
• Report Number: 1049092-2019-00244
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1