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

Catalog Number SCF10X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation (2443)

Event Date 09/04/2014

Event Type  Injury  

Manufacturer Narrative

The events of blisters and exposure of the device 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.

Event Description

Healthcare professional reported placement of seri surgical scaffold in the left breast during mastectomy reconstruction on (b)(6) 2013.Post-implantation and beginning (b)(6) 2014, the site developed "small blisters inferior to the incision line", and could see exposure of the implanted seri.Patient was treated with antibiotics.A "mass" of scaffold material was removed on (b)(6) 2014, and a "three by two and a half inch" piece of scaffold was removed on (b)(6) 2015.The symptoms resolved and further treatment was not necessary.The majority of the device remains implanted.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5643497
• MDR Text Key: 44836655
• Report Number: 8020862-2016-00028
• 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: 04/18/2016

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: 05/31/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12052101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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: NON-ALLERGAN TISSUE EXPANDER
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR