MAUDE Adverse Event Report: ALLERGAN 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)

Event Date 12/24/2014

Event Type  Injury  

Event Description

Physician reported right side implantation of seri to support primary breast reconstruction on (b)(6)2014.Post- implantation on (b)(6) 2014, the patient presented with "spitting of the seri through intact skin not the through the incision" 1cm above the incision.The physician prescribed bactrim and bactroban ointment at that time.No other treatment was prescribed.The device remains implanted and will not be returned.

Manufacturer Narrative

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.

Manufacturer Narrative

Medwatch sent to fda on (b)(6) 2016.The event of inadequate tissue ingrowth 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 done.

Event Description

Physician reported right side implantation of seri to support primary breast reconstruction on (b)(6) 2014.Post-implantation on (b)(6) 2014, the patient presented with spitting of the seri through intact skin not through the incision 1 cm above the incision.The physician prescribed bactrim and bactroban ointment at that time.No other treatment was prescribed.The device remains implanted and will not be returned.Physician reported the patient continued to "spit out of the wound", and additionally, removal of two "2-3 inch long strands of non-integrated serion 03/25/2016 and another on 04/01/2016.No further treatment is planned.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 4804312
• MDR Text Key: 5926631
• Report Number: 3008374097-2015-00033
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

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: 10/31/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12091001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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: 70 YR