MAUDE Adverse Event Report: SONOGRAM ; SYSTEM, IMAGING, ULTRASONIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076)

Event Date 05/29/2018

Event Type  Injury  

Event Description

Had a sonogram and next day had a skin infection emerged on my chest (md said could be (b)(6)), have been on clindamycin for 10 days and following with another 10 days; (b)(6).

• Brand Name: SONOGRAM
• Type of Device: SYSTEM, IMAGING, ULTRASONIC
• MDR Report Key: 7609592
• MDR Text Key: 111520379
• Report Number: MW5077906
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 88