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

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pocket Erosion (2013)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 11/25/2015.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.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.The device has not been returned.Therefore, no analysis or testing has been performed.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 the severity of the reported event suggests that medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported one month post implantation of seri device "seeped through the skin." no further information was provided, including if treatment has been provided.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• 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: krista alvarado ; 301 w howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 5251480
• MDR Text Key: 32178072
• Report Number: 8020862-2015-00012
• 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: Other
• Type of Report: Initial
• Report Date: 03/05/2014

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 SERI SURGICAL SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 11/25/2015
• 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