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); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of "possible infection", "inflammation", "purulent drainage", capsular contracture (baker grade iv), and "not integrated" 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."device labeling addresses the reported event of infection and inflammation as follows: adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.".

Event Description

Physician reported a procedure to correct left side breast capsular contracture occurring on (b)(6) 2016.The physician noted "possible infection", inflammation, "purulent drainage", capsular contracture (baker grade iv), and "not integrated" for a left side seri scaffold during the procedure.Seri and the concomitantly placed silicone gel breast implant were explanted.

Manufacturer Narrative

Additional data: age/date of birth, date of event, describe event or problem, relevant tests/lab data, brand name, model #/lot #, implant date, device manufacture date.Corrected data: relevant tests/lab data.

Event Description

Events have resolved without sequelae as of 09/31/2016.

Manufacturer Narrative

From the review of the device history records for lot p14071801, there is no evidence in the manufacturing history of lot p14071801 to suggest that a manufacturing error caused the adverse event reported.

Event Description

Physician reported a procedure to correct left side breast capsular contracture occurring on (b)(6) 2016.The physician noted "possible infection", inflammation, "purulent drainage", capsular contracture (baker grade iv), and "not integrated" for a left side seri® scaffold during the procedure.Seri® and the concomitantly placed silicone gel breast implant were explanted.Events have resolved without sequelae as of (b)(6) 2016.

• 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: 6011976
• MDR Text Key: 56920558
• Report Number: 8020862-2016-00045
• 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,Followup
• Report Date: 03/02/2017

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: 07/31/2017
• Device Catalogue Number: SCF15X25AGEN
• Device Lot Number: P14071801A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2016; 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2014
• 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 SILICONE BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR