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

Catalog Number SCF5X15AGEN

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

Patient Problems Capsular Contracture (1761); Inflammation (1932); Seroma (2069)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 07/26/2016.The events of inflammation, capsular contracture, seroma, and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The device was discarded and will not be returned.Therefore, no analysis or testing will be done.Device labeling addresses the reported event of inflammation as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.".

Event Description

Healthcare professional reported that patient presented with 'rawness', 'redness', and capsular contracture, baker grade iii.Earlier patient was implanted with ser on (b)(6) 2015 in the ¿sling¿ position to treat device migration of the breast implant identified as ¿bottom-out¿.On (b)(6) 2016, physician treated the capsular contracture with capsulorrhaphy and ¿very easily removed¿ most of the seri scaffold as there was almost no tissue integration.Physician noted "a small amount of serous fluid" in the pocket.

Manufacturer Narrative

From the review of the device history records for lot p14022601a 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 p14022601a to suggest that a manufacturing error caused the ae reported.

Event Description

Healthcare professional reported that patient presented with 'rawness', 'redness', and capsular contracture, baker grade iii.Earlier patient was implanted with seri® on (b)(6) 2015 in the ¿sling¿ position to treat device migration of the breast implant identified as ¿bottom-out¿.On (b)(6) 2016, physician treated the capsular contracture with capsulorrhaphy and ¿very easily removed¿ most of the seri® scaffold as there was almost no tissue integration.Physician noted "a small amount of serous fluid" in the pocket.

• 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: 5822785
• MDR Text Key: 50458093
• Report Number: 8020862-2016-00039
• 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: 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: 03/31/2017
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P14022601A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/26/2016
• 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: 04/30/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR