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

Model Number 418000

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Brand name: fecal management system (specific system not identified, due to absence of lot information.).Based on the available information, this event is deemed to be a serious injury.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the patient had a "full thickness pressure injury to the perineum".It was unknown how long the fecal management system (fms) device had been in place, the patient was a transfer from another facility and had the fms device in place.The patient was described as being "very sick and possibly expired".Multiple attempts were made to obtain more information regarding this patient and the device.The territory manager will be going to the hospital on (b)(6) 2020 for follow-up in-servicing in the intensive care units.No additional information was received.No photos received.No lot number available.

• 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: 10931653
• MDR Text Key: 219312908
• Report Number: 1049092-2020-00184
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1