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

Catalog Number SCF5X15AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event details has been requested.No additional information is available at this time.The events of capsular contracture and "redness" are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The device has not been returned, therefore, no analysis or testing has been done.These events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported implantation of seri surgical scaffold and a concomitant non-allergan breast implant on (b)(6) 2015 and "redness".The patient was scheduled for surgery to have the device removed.

• 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: krista alvarado ; 301 w howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 5192347
• MDR Text Key: 30011587
• Report Number: 8020862-2015-00007
• 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: 10/08/2015

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: 03/31/2017
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P14030301A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Patient Outcome(s): Required Intervention