MAUDE Adverse Event Report: SOFREGEN, INC SERI SURGICAL SCAFFOLD

Catalog Number SCF15X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Seroma (2069); Therapeutic Effects, Unexpected (2099)

Event Date 08/18/2016

Event Type  Injury  

Event Description

On 14-jun-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 three was a (b)(6) female ((b)(6)) that came to the physician's office on (b)(6) 2016 for a regular check-up post removal and replacement of breast implants ((b)(6) 2016).Seri surgical scaffold (lot: p14073101a, expiry: aug-2017, product code: scf15x25agen) was used in the procedure.The patient noticed drainage under the incision.The physician opened the area and a seroma was noted.A drain was placed and no infection was noted.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: 6944200
• MDR Text Key: 89284052
• Report Number: 3013417188-2017-00018
• 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: 10/12/2017
• 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: P14073101A
• 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: 50 YR