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

Catalog Number SCF10X25AGEN

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

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Purulent Discharge (1812)

Event Date 01/19/2014

Event Type  Injury  

Event Description

Healthcare professional reported post-mastopexy and implantation of seri, patient presented with left side "2mm cyst pocket area with purulent discharge" and infection.The inframammary incision line was inflamed, and physician examined the patient in the operating room, where the seri device was found to be "completely non-incorporated" and was subsequently entirely explanted.Patient was prescribed ciprofloxacin, and adverse events have resolved since explant surgery.

Manufacturer Narrative

The device availability for return is unk.Therefore allergan may not receive it and no analysis or testing may be done.The events of cyst., drainage, infection, 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.See scanned page.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; 200 boston avenue; medford MA 02155 000
• Manufacturer (Section G): ALLERGAN; 200 boston avenue; medford MA 02155 000
• Manufacturer Contact: karen herrera ; 71 s los carneros road; goleta, CA 93117-0000 ; 8059615405
• MDR Report Key: 3703442
• MDR Text Key: 4251610
• Report Number: 3008374097-2014-00012
• 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
• Report Date: 02/04/2014

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: 11/30/2013
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12091801C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR