MAUDE Adverse Event Report: SOFREGEN, INC SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/25/2016

Event Type  Injury  

Event Description

On 19-jul-2017, sofregen received an email from a cosmetic care coordinator: "one of dr.(b)(6)'s patients experienced unincorporation bilaterally and eventually underwent several surgeries to remove the product and them ultimately removing her breast implants as well." on 25-jul-2017, additional information was received from the cosmetic care coordinator.On (b)(6) 2016, a patient ((b)(6)) had the seri surgical scaffold implanted to help with breast implants that were dropping.The seri was being used as a sling to hold the implants in place.On (b)(6) 2016, the seri in the left breast was removed and on (b)(b)(6) 2016, the seri in the right breast was removed.The seri was not keeping the breast implants in place.On (b)(6) 2016, the breast implants were replaced.On (b)(6) 2017, she is having surgery to have strattice implanted.No additional information was provided.

• Brand Name: SERI SURGICAL SCAFFOLD
• Type of Device: SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): SOFREGEN, INC; medford MA
• Manufacturer Contact: 200 boston ave.; suite 1100; medford, MA 02155-4288 ; 6176518873
• MDR Report Key: 6894077
• MDR Text Key: 87355897
• Report Number: 3013417188-2017-00012
• 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: Other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 09/26/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR