MAUDE Adverse Event Report: ALLERGAN SERI SURGICAL SCAFFOLD (US)

Catalog Number SCF10X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation (2443)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Healthcare professional reported right side "blister", and exposure of a seri surgical scaffold.Device was originally placed (b)(6) 2013 to support 2-stage mastectomy reconstruction.The patient had a permanent breast implant placed (b)(6) 2014, and nipple reconstruction (b)(6) 2014.Patient presented with the "blister" on (b)(6) 2015, and was treated with bactrim and bactroban.The blister subsequently opened exposing the seri device.The site was debrided.The device remains implanted and no further treatment was planned.

Manufacturer Narrative

The events of "blister and exposure are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• 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: 4729616
• MDR Text Key: 18026603
• Report Number: 3008374097-2015-00027
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2015

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: 11/30/2013
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12091801B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: PATIENT WAS CONCOMITANTLY IMPLANTED WITH A TISSUE,; BREAST IMPLANT.; EXPANDER AND LATER A NON-ALLERGAN PERMANENT,
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR