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

Catalog Number SCF10X25AGEN

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2014

Event Type  Injury  

Event Description

Healthcare professional reported implantation of seri and concomitant tissue expander on (b)(6) 2014 as part of right side mastectomy reconstruction surgery.Post-implantation, the healthcare professional noted extrusion and that the bare seri was "exposed" to the air on or about (b)(6) 2014.The device was completely removed on (b)(6) 2014.The device was completely unincorporated with the patient's tissue.The device was discarded, and is unavailable for return.

Manufacturer Narrative

The events of extrusion 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 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.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd.; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4283562
• MDR Text Key: 16990939
• Report Number: 3008374097-2014-00131
• 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: 11/04/2014

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: 08/31/2016
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P13081301A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Treatment: ALLERGAN SALINE TISSUE EXPANDER
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR