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

Catalog Number SCF10X25AGEN

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Fluid Discharge (2686)

Event Date 12/04/2014

Event Type  Injury  

Event Description

Healthcare professional reported implantation of seri surgical scaffold along with a concomitant breast implant to reinforce tissue located at the left side inframammary fold on (b)(6) 2014.On (b)(6) 2014, the pt presented with a hole on the left breast approximately 1cm x 8mm in size exposing the scaffold device and expressing drainage.The healthcare professional decided to remove the devices on (b)(6) 2015.Upon removal, the device displayed "no adhesion" to the pt's tissue, and the tissue exhibited an "inflammatory response." the healthcare professional attributed the exposure and the inflammatory response at least partially to the seri surgical scaffold.The device was completely removed and discarded.

Manufacturer Narrative

The event of inflammation, inadequate tissue ingrowth, exposure and drainage are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive the device and no analysis or testing will be done.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: UNK
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4638162
• MDR Text Key: 5757828
• Report Number: 3008374097-2015-00019
• 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: 01/30/2015

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: 09/30/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12082801B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: MASSAGE THERAPY; PT WAS IMPLANTED WITH A CONCOMITANT ALLERGY STYLE,; 410 BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR