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

Catalog Number SCF10X25AGEN

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

Patient Problem Fluid Discharge (2686)

Event Date 03/05/2014

Event Type  Injury  

Event Description

Company representative reported post implantation of seri in the left breast, patient presented with "persistent drainage." culture results negative for infection.Exploratory surgery was performed which found sixty percent of the seri device was not fully incorporated.Physician placed a drain and non-incorporated portion of seri was explanted without availability for return.

Manufacturer Narrative

The explanted portion of the device is not available for return.Therefore, allergan will not receive it and no analysis or testing will be done.The events of drainage 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.While device-relatedness casualty cannot be determined, allergan is reporting the event out of an abundance of caution.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: OXF
• 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 ; 8059615867
• MDR Report Key: 3763455
• MDR Text Key: 4488064
• Report Number: 3008374097-2014-00016
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/05/2014

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: 08/31/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12081301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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