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

Catalog Number SCF15X25AGEN

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

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

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding this event has been requested.No additional information is available at this time.The reported events of seroma, inadequate tissue ingrowth, and capsular contracture, baker grade iii, 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

Physician reported a patient with seri® surgical scaffold experienced right side capsular contracture, baker grade iii and ¿there were areas of fluid collection of thickened capsule¿.Physician noted ¿the seri® silk scaffold was incorporated; however, it was removable by gentle peeling away with an underlying granulation tissue and release of ethibond sutures¿.

Event Description

Additional information received from healthcare professional that the events have resolved without sequelae.

• 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: 6395381
• MDR Text Key: 69611220
• Report Number: 8020862-2017-00003
• 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,Followup
• Report Date: 05/03/2017

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: 11/30/2017
• Device Catalogue Number: SCF15X25AGEN
• Device Lot Number: P14100101A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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
• Treatment: ALLERGAN INSPIRA SMOOTH SILICONE BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR