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

Model Number SDA-SYS-3000-3D

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

Patient Problem Abrasion (1689)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

Device identifier: 15420045505636.

Event Description

It was reported that during a mammography procedure, the patient got her head stuck between the compression paddle and the face shield.The patient lowered her head during the lmlo image acquisition and her neck got stuck between the face shield and the compression paddle after the exposure, when the paddle automatically released.The patient had an abrasion on her neck.The patient was sent to the emergency room.A field engineer examined the device and found that the compression release clutch slips during compression.The field engineer changed the compression release height and the system passed all tests and met the manufacturer´s specifications.No additional information available.

• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18580814
• MDR Text Key: 333738506
• Report Number: 1220984-2024-00004
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDA-SYS-3000-3D
• Device Catalogue Number: SDA-SYS-3000-3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other