MAUDE Adverse Event Report: ALLERGAN UNK SCAFFOLD

Catalog Number UNK SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 02/26/2015

Event Type  Injury  

Event Description

Health professional reported right side extrusion of seri implanted in the breast.

Manufacturer Narrative

The reporter has declined to provide allergan further information regarding event, product, or patient details.The event of extrusion is a physiological complication, and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling addresses the reported event of extrusion 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 had not been established.

• Brand Name: UNK SCAFFOLD
• 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: 4634894
• MDR Text Key: 21332624
• Report Number: 3008374097-2015-00023
• 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: 02/26/2015

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 Catalogue Number: UNK SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/24/2015
• 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