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 Problems Abscess (1690); Capsular Contracture (1761)

Event Type  Injury  

Manufacturer Narrative

The events of abscess and capsular contracture 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 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.

Event Description

The physician reported, "(b)(6) 2015 seri® placed with natrelle® implants - progressive capsular contracture and fluid - (b)(6) 2016 sterile abscess drained and implants and seri® removed".

Manufacturer Narrative

From the review of the device history records for lot p12102201a all non-conformances were addressed and were determined to have no impact on product quality and safety.There is no evidence in the manufacturing history of lot p12102201a to suggest that a manufacturing error caused the ae reported.

Event Description

The physician reported, "(b)(6) 2015 seri® placed with natrelle® implants, progressive capsular contracture and fluid.On (b)(6) 2016 sterile abscess drained and implants and seri® removed".

• 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: 5529829
• MDR Text Key: 41284455
• Report Number: 8020862-2016-00023
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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: 07/31/2016
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12102201A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2013
• 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
• Patient Outcome(s): Required Intervention