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

Model Number 421630

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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.A return sample for evaluation is not expected.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.Additional patient/event details have been requested but, not provided to date.The lot number was not provided.Therefore, we are unable to determine the specific third party manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported the patient experienced bleeding from around the inserted protect fecal management system device (fms).The product was discontinued.The nurse reported the bleeding stopped once the device was removed.The nurse stated she estimated ¿the end user lost two (2) units of blood because the end user required two (2) units of a blood transfusion.¿ the length of time the device was in use when the bleeding occurred was reported as unknown.No further event details or patient information was provided.

• Brand Name: FMS PROTECT
• 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
• MDR Report Key: 8507349
• MDR Text Key: 141725364
• Report Number: 1049092-2019-00185
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K162906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2019
• 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
• Treatment: ANTICOAGULANT MEDICATION