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

Catalog Number SCF10X25AGEN

Device Problems Material Disintegration (1177); Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Pocket Erosion (2013)

Event Date 11/03/2013

Event Type  Injury  

Event Description

Company representative reported following a mastopexy procedure performed with implantation of seri, pt presented with left side "blisters" at the implant site.Antibiotics were prescribed at the onset of symptoms, however, physician also noted extrusion of the device in a "nickel-quarter sized area" and that these portions of the device were "un-incorporated".Non-adherent pieces of seri were initially removed, and eventually the remainder of the device was explanted.Physician reports there was "no skin breakdown or redness".

Manufacturer Narrative

The device has been explanted but the availability for return is unk.Therefore allergan may not receive it and analysis or testing may not be done.The events of extrusion, irritation/inflammation, and non-adherence are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported events of extrusion and irritation/inflammation as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion".This event is reported against the left side, and is the same event and the same pt reported under mdr id # 3008374097-2014-00007.(b)(4).

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd.; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3591185
• MDR Text Key: 4035468
• Report Number: 3008374097-2014-00005
• 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,Company Representative
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 12/18/2013

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: 06/30/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12060401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR