MAUDE Adverse Event Report: NEOMED, INC.; ENTERAL FEEDING TUBE

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

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Neomed has contacted user facility for additional information regarding this event 16 april 2019, 24 april 2019, and 30 april 2019.Additional information has not yet been received.

Event Description

A perforation was identified in a neonatal patient who had a neomed polyurethane feeding tube placed for gastric venting.

• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct.; suite 112; woodstock GA 30188
• Manufacturer (Section G): SYNECCO, CO., LTD.; b801 rongan plaza; no. 700 south tiantong road; ningbo, 31510 0; CH 315100
• Manufacturer Contact: melinda smith ; 100 londonderry court; suite 112; woodstock, GA 30188 ; 7704855188
• MDR Report Key: 8737034
• MDR Text Key: 149269228
• Report Number: 3006520777-2019-00005
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention