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

Lot Number 20180825

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

Patient Problems Internal Organ Perforation (1987); Abdominal Distention (2601)

Event Date 03/16/2019

Event Type  Injury  

Event Description

Gastric perforation identified after the baby showed signs and symptoms of abdominal distention.Periodogram revealed intra-abdominal air.Pediatric surgery consulted.Gastric perforation identified and corrected in surgery.

• Brand Name: NEOMED
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): NEOMED, INC.; woodstock GA
• MDR Report Key: 8479497
• MDR Text Key: 140829712
• Report Number: 8479497
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2019

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: Health Professional
• Device Expiration Date: 08/24/2021
• Device Lot Number: 20180825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2019
• Distributor Facility Aware Date: 03/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1