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

Model Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/11/2017

Event Type  Injury  

Event Description

On 30-oct-2017, the following information was received: "with patient (b)(6), the order of events of the ae are as follows: surgery date: (b)(6) 2017.A small amount of drainage and change in his right nipple areolar complex.At the 2 o'clock position there is approximately 3 mm area of thinning with possible exposure of the underlying mesh: (b)(6) 2017.A small area of exposure that is 4 mm in diameter of mesh which was extracted: (b)(6) 2017.An area of mesh exposure has nearly fully resolved: (b)(6) 2017.On (b)(6) 2017, the reporter provided more information.On (b)(6) 2017, male the patient had a procedure in the office that required local anesthetic for the removal of an exposed piece of seri surgical scaffold (4 mm in size).On (b)(6) 2017, the area of exposure was the following information was provided regarding the seri surgical scaffold: lot # p15012601a, expiry: feb 2018, product code: scf5x15agen.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: 7067203
• MDR Text Key: 93210427
• Report Number: 3013417188-2017-00020
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P15012601A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• 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
• Patient Outcome(s): Required Intervention