MAUDE Adverse Event Report: ALLERGAN SERI SURGICAL SCAFFOLD (US); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number SCF5X15AGEN

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 04/15/2015

Event Type  Injury  

Event Description

Healthcare professional reported implantation of seri surgical scaffold and concomitant silicone breast implant on (b)(6) 2015 during revision to a previous right side breast augmentation.Approximately six weeks later, the patient presented with "red breast", and "cellulitis at the incision".The wound was draining, and tested positive for (b)(6).The patient was treated with antibiotics and partial removal of the seri device on (b)(6) 2015.A portion of the device remains implanted.The physician noted that prior to treatment, the patient "cut the drains" and attached plastic sandwich bags to them in order to "fit better under her clothing".

Manufacturer Narrative

Unique identifier (udi) # not applicable.The event of infection is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w. howard lane suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4808067
• MDR Text Key: 16563734
• Report Number: 3008374097-2015-00034
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P14030301A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: PATIENT WAS IMPLANTED WITH CONCOMITANT ALLERGAN; SILICONE BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR