MAUDE Adverse Event Report: ECO-MED PHARMACEUTICAL, INC. RED MEDICAL SUPPLIES - ULTRASOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B061

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Congenital Defect/Deformity (1782); Fistula (1862); Obstruction/Occlusion (2422)

Event Date 12/24/2020

Event Type  Injury  

Event Description

I was using an ultrasound gels and lotions manufactured by eco-med pharmaceutical, inc.Recalled due to risk of bacteria contamination.The fda has identified this as a class i recall, the most serious type of recall.Use of these devices may cause serious injuries or death.We were notified about this through our purchaser of (b)(6).I used this ultrasound gel sometimes multiple time a day to hear my sons heartbeat in the womb.After using for two full months i was given a late term ultrasound at 25 weeks and my son was found to have blockages in his small intestine.He was also born then with a anal blockage and fistula.He has had two successful surgeries removing this blockages with one more to go this (b)(6) 2021 to remove the colostomy that was put into place.We were very shocked by this birth defect and with no other issues with my sons brain or heart.It has made me research what went wrong and this could be a reason because the bacteria can stop blood flow and create skin issues.I just wanted to notify for further research so this could give reason or stop it from happening to another family in the future.Ultrasound that found blockages in my son's small intestine creating duodenal atresia.Duodenal artresia and imperforated anus that has been repaired.Fda safety report id # (b)(4).

• Brand Name: RED MEDICAL SUPPLIES - ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICAL, INC.
• MDR Report Key: 12590187
• MDR Text Key: 275893596
• Report Number: MW5104460
• Device Sequence Number: 1
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/08/2023
• Device Lot Number: B061
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 5 MO
• Patient Weight: 7