MAUDE Adverse Event Report: SOFREGEN MEDICAL, INC SERI SURGICAL SCAFFOLD

Device Problem Use of Device Problem (1670)

Patient Problems Foreign Body Reaction (1868); Breast Mass (2439)

Event Type  Injury  

Event Description

On 07/18/2017, the following information was received via email: "had an event with seri at 3 years, being balled up and needing to be removed.In my limited experience i have not heard of such an event." no additional information was provided.On 7/21/2017: dr.(b)(6) called and supplied additional information.He reported that a patient had come in 2 or 3 years ago and her breasts had bottomed out from a previous augmentation.At this time, he implanted the seri surgical mesh at the base of the breasts for extra support.Then 2 or 3 months ago she came into the office with a lump on the underside of one breast.She was referred to a surgeon who decided to remove the lump.The lump was removed, there was scar tissue surrounding the seri mesh that was balled up.The surgeon stated the patient had a foreign body reaction.Dr.Rosen stated he has used the seri with no issues in the past.He was not in the office and was unable to provide lot number.He will check in with his office next week and call us back.On 08/11/2017: spoke with the physician again and he was unable to give any additional information.The facility were the "balled up seri" was removed would not provide any additional information to dr.(b)(6).

• Brand Name: SERI SURGICAL SCAFFOLD
• Type of Device: SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): SOFREGEN MEDICAL, INC
• Manufacturer Contact: 200 boston ave; suite 1100; medford, MA 02155-4288
• MDR Report Key: 6894035
• MDR Text Key: 87354065
• Report Number: 3013417188-2017-00010
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BREAST IMPLANTS-IMPLANT DATE OF 2-3 YEARS AGO
• Patient Outcome(s): Required Intervention