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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRASOUND SCANNER

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ULTRASOUND SCANNER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Flatus (1865); Pain (1994); Burning Sensation (2146); Abdominal Distention (2601)
Event Date 09/24/2018
Event Type  Injury  
Event Description
About an hour after a pelvic ultrasound/transvaginal ultrasound, i started to have labor-like pain.I started feeling bloated.I got sharp pain when eating solid food.On the second day, i started hearing gangling and buddling in my abdomen.I have previously had heat sensation from ultrasound and informed the tech prior to the procedure.I suspect that i suffered cavitation (gas formation) from the ultrasound.I am still in severe pain.Transvaginal ultrasound was performed at rush medical ctr, radiology, chicago il.I called the clinic and asked them to check their equipment, and amend my record with the after-effects.The records was not amended.My concerns was ignored.Property of (b)(6).
 
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Brand Name
ULTRASOUND SCANNER
Type of Device
ULTRASOUND SCANNER
MDR Report Key7922583
MDR Text Key122445137
Report NumberMW5080227
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/27/2018
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 Other
Device Expiration Date09/24/2018
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/28/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age51 YR
Patient Weight57
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