MAUDE Adverse Event Report: SOFREGEN, INC SERI SURGICAL SCAFFOLD

Catalog Number SCF15X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/14/2017

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 one was a (b)(6) year old female (physician's office id number: (b)(4)) that came to the physician's office for a regular check-up post bilateral mastaplexy (surgery date: (b)(6) 2016).Seri surgical scaffold (lot: p14071901a, expiry: 31-aug-2017, product code: scf15x25agen) was used in the procedure.The patient had two areas of redness.One area was on the lateral aspect of the upper left breast and the other was the medial area of the same breast.Both areas were opened, irrigated and debrided.Both areas had a small piece of mesh showing that was clipped and thrown away.Cultures were done on (b)(6) 2017, but the results were not yet available.The patient's normal medications included: exforge, abilify, and triazolam.The patient was prescribed septra ds for two weeks.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: 6940026
• MDR Text Key: 89243014
• Report Number: 3013417188-2017-00016
• 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: 09/27/2017

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 Expiration Date: 08/31/2017
• Device Catalogue Number: SCF15X25AGEN
• Device Lot Number: P14071901A
• 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: 68 YR