MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number SDM-05000-3DC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Tears (2516); Skin Infection (4544)

Event Date 02/21/2023

Event Type  Injury  

Event Description

It was reported that during a selenia dimensions procedure on (b)(6) 2023, the gantry was shaking during tomo causing patient injury.The patient did not initially report an injury but later followed up with the site indicating that she suffered a skin tear + indentation.The patient stated that the tower ¨jumped 4 times¨.The following week the patient went to her primary care which reported a skin tear and subsequent infection that required medication to be treated.A field engineer examined the equipment and was unable to recreate the jerking tomo motion that the customer reported.Vta bolts were checked and calibrations were performed.The only issue found was that the grid from motor was not functioning properly.The grid assembly was replaced and gain calibrations performed and the system met the manufacturer´s specifications.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Type of Device: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16600139
• MDR Text Key: 311931640
• Report Number: 1220984-2023-00025
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDM-05000-3DC
• Device Catalogue Number: SDM-05000-3DC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other