MAUDE Adverse Event Report: HOLOGIC, INC. MAMMOPAD; FOAM PAD CUSHION

Model Number MP301

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Skin Inflammation (2443)

Event Date 07/02/2014

Event Type  Injury  

Event Description

The customer reported a patient that had a mammogram on (b)(6) 2014 returned to the facility on (b)(6) 2014 to state she had a rash under her breast.The patient was advised by a doctor that the rash looked like adhesive dermatitis.The patient reported she was treated with a medicated cream that greatly improved the rash.

Manufacturer Narrative

The mammopad is a latex-free foam pad cushion used in mammography for patient comfort.The mammopad that was used on this particular patient was discarded, so no evaluation of the actual device could be performed.Hologic did however have the contract manufacture review their manufacturing process and evaluate retained samples of mammopad materials sent to this particular site.No abnormalities in the process or materials were identified.The user site is investigating other reasons as to why this rash occurred.

• Brand Name: MAMMOPAD
• Type of Device: FOAM PAD CUSHION
• Manufacturer (Section D): HOLOGIC, INC.; 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: sharon floyd ; 37 apple ridge rd.; danbury, CT 06810 ; 2037318449
• MDR Report Key: 4008229
• MDR Text Key: 4773543
• Report Number: 1220984-2014-00005
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MP301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SELENIA FULL FIELD MAMMOGRAPHY SYSTEM
• Patient Outcome(s): Other