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

Catalog Number SCF10X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Date 04/02/2014

Event Type  Injury  

Event Description

Healthcare professional reported a pt who presented on (b)(6) 2014, with a left side seroma due to the "textured implant rubbing against the seri scaffold." left side infection was subsequently diagnosed.Pt was treated with bactrim and on (b)(6) 2014, both the seri and concomitant non-allergan device were explanted and discarded.

Manufacturer Narrative

The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive it and no analysis or testing will be done.The event of infection and seroma are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device relation of the seri to the events are unk by the physician, however it is allergan medical's approach to compliance to resolve all doubts in favor of reporting.

• 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 ; 8059615867
• MDR Report Key: 3827621
• MDR Text Key: 4501243
• Report Number: 3008374097-2014-00028
• 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: Other
• Type of Report: Initial
• Report Date: 04/10/2014

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: P12073001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/07/2014
• 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
• Treatment: NON-ALLERGAN TEXTURED SILICONE BREAST DEVICE; DEXAMETHASONE; IMPLANTED:; EXPLANTED:
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR