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 Problem Unspecified Infection (1930)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

The events of "erosion", infection, 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.The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive the device and no analysis or testing will be done.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." these events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported right side exposure.Upon further investigation, the physician indicated the device was used for inframammary fold support during revision to breast augmentation on (b)(6) 2014.Post implantation on (b)(6) 2015, the patient presented with "erosion" at the incision site.The device was found to show no integration with the patient's tissue, and was completely removed on (b)(6) 2015.The physician indicated the site had become infected, but did not indicate whether the infection occurred before or after the scaffold device was removed.This led to removal and exchange of the concomitant breast implant on (b)(6) 2015.

• 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: tracy kough ; 301 w howard lane; suite 100; austin, TX 78753 ; 5135270529
• MDR Report Key: 5279653
• MDR Text Key: 33098029
• Report Number: 8020862-2015-00039
• 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: 11/18/2015

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: 10/31/2016
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P13091001A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 34 YR