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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC IMAGING SYSTEM

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HOLOGIC, INC. HOLOGIC IMAGING SYSTEM Back to Search Results
Model Number PRD-01702
Device Problem Unintended Arm Motion (1033)
Patient Problems Crushing Injury (1797); Bone Fracture(s) (1870)
Event Date 02/09/2017
Event Type  Injury  
Event Description

Patient presented for a mammogram and ultrasound. He indicated that he couldn't stand for the exam, so he was positioned sitting down. While setting up for the image the patient was heard yelling and it was noted the c-arm of the unit had come down on the patient's left femur. The unit was raised and patient complained of left heel pain. He was subsequently taken to the emergency room where imaging studies confirmed a comminuted calcaneal fracture.

 
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Brand NameHOLOGIC IMAGING SYSTEM
Type of DeviceHOLOGIC IMAGING SYSTEM
Manufacturer (Section D)
HOLOGIC, INC.
newark DE 19702
MDR Report Key6363883
MDR Text Key68623687
Report NumberMW5068153
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPRD-01702
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? 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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/24/2017 Patient Sequence Number: 1
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