MAUDE Adverse Event Report: SOFREGEN, INC SERI SURGICAL SCAFFOLD

Catalog Number SCF15X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Necrosis (1971); Therapeutic Effects, Unexpected (2099)

Event Date 03/27/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a physician's office contacted sofregen to report events associated with seri surgical scaffold.The office had four patients with complications regarding the seri surgical scaffold.Patient number two was a (b)(6) female (physician's office id number: 13893) that came to the physician's office for a regular check-up post bilateral mastaplexy (surgery date: (b)(6) 2017).Seri surgical scaffold (lot: p14080101a, expiry: aug-2017, product code: scf15x25agen) was used in the procedure.The patient had a "fluffy areola".Debridement was done and there was no notation that the seri surgical scaffold was visible.The patient came back to the office with the same issue on (b)(6) 2017.The physician noted some necrotic tissue in the same area as before and offered to again do debridement and the patient declined and when to another office for treatment.The patient's medical history was unknown.The device was not explanted.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 avenue; suite 100; medford, MA 02155-4288 ; 6176618873
• MDR Report Key: 6940059
• MDR Text Key: 89252337
• Report Number: 3013417188-2017-00017
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SCF15X25AGEN
• Device Lot Number: P14080101A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• 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
• Patient Age: 43 YR