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

Catalog Number SCF10X25AGEN

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 09/08/2016.The device has been discarded and will not be returned.Therefore, no analysis or testing will be done.The events of infection, cellulitis, "a ¿pinhole¿ on the underside of the breast through which the seri® was visible", and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event of infection as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.".

Event Description

Physician reported the patient underwent bilateral reconstruction revision on (b)(6) 2015 during which time style 20 silicone gel breast implants were placed.A single piece of seri® scaffold was placed bilaterally at that time; 10 x 23 cm on the right side in the inframammary to lateral breast border position and 6 x 2 cm on the left side in a triangular shape to assist with a thin capsule following radiation therapy.Seri® was dipped in saline prior to implantation and the surgical site was irrigated with triple antibiotic.On an unspecified date, the patient experienced an infection, was hospitalized, and given antibiotics via iv.On (b)(6) 2016, the right side seri® and concomitantly placed breast implant were removed due to infection which was later clarified to be cellulitis.Approximately 75% of the right side seri® was unincorporated.On (b)(6) 2016, the left side seri® and concomitantly placed breast implant were also removed due to a staph infection.Physician additionally found there to be a ¿pinhole¿ on the underside of the breast through which the seri® and breast implant were visible.100% of the left side seri® was unincorporated.Physician stated that 100% of the seri® scaffold was removed from both sides.All explanted devices have been discarded.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer (Section G): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5935419
• MDR Text Key: 54153530
• Report Number: 8020862-2016-00043
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P13101601A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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: STYLE 20 SILICONE BREAST IMPLANT (B)(6) 2015
• Patient Outcome(s): Hospitalization; Required Intervention