MAUDE Adverse Event Report: SOFREGEN, INC SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

On 19-may-2017, sofregen became aware of an adverse event experienced by a consumer of unknown age and gender with the use of the seri surgical scaffold.The following information was provided by allergan.A physician is dissatisfied with the seri surgical scaffold relative to a patient's outcome.A case in 2015, in which the seri scaffold did not become incorporated.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: 6907360
• MDR Text Key: 88012382
• Report Number: 3013417188-2017-00015
• 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: 10/02/2017
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2017
• 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