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U.S. Department of Health and Human Services

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

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ECO-MED PHARMACEUTICAL, INC. RED MEDICAL SUPPLIES - ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
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).
 
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Brand NameRED MEDICAL SUPPLIES - ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICAL, INC.
MDR Report Key12590187
MDR Text Key275893596
Report NumberMW5104460
Device Sequence Number1
Product Code ITX
Number of Events Reported1
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 Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberB061
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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