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

Catalog Number SCF10X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Seroma (2069)

Event Date 12/23/2014

Event Type  Injury  

Event Description

Health professional reported bilateral implantation of seri on (b)(6) 2014 alongside concomitant breast implants during revision to breast augmentation surgery.Post-implantation, the patient developed a recurrence of capsular contracture.Baker grade iv, and the breast implants were removed on (b)(6) 2014.Serous fluid was noted in both pockets upon removal of the breast implants.The seri device remains implanted and is unavailable for return.

Manufacturer Narrative

The event of capsular contracture and seroma 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.The device remains implanted and will not be returned.Therefore, no analysis or testing will be done.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155 000
• Manufacturer Contact: krista alvarado ; 301 w. howard lane, ste. 100; austin, TX 78753-0000 ; 5128132638
• MDR Report Key: 4924629
• MDR Text Key: 22244525
• Report Number: 3008374097-2015-00009
• 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: 01/15/2015

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: 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: 04/15/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: SILICONE BREAST IMPLANTS.; PATIENT WAS CONCOMITANTLY IMPLANTED WITH ALLERGAN
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR