MAUDE Adverse Event Report: HOLOGIC, INC. MULTICARE PLATNIUM; STEREOTACTIC BREAST BIOPSY SYSTEM

Model Number 8-004-0017

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  No Answer Provided  

Event Description

When our field service engineer was on site it was reported "that a patient was burned by the gooseneck lamp" on our multicare platinum biopsy table.This happened approximately 2 years ago, (exact date unknown.No additional information was able to be obtained.

• Brand Name: MULTICARE PLATNIUM
• Type of Device: STEREOTACTIC BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: debra rosenberg ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2032074512
• MDR Report Key: 6045553
• MDR Text Key: 58018448
• Report Number: 1220984-2016-00031
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO30666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8-004-0017
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other