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 Problems Cellulitis (1768); Inflammation (1932); Necrosis (1971)

Event Date 03/19/2014

Event Type  Injury  

Event Description

Company rep reported post implantation of seri during a left side revision augmentation, pt presented on (b)(6) 2014 with left side cellulitis and inflammation causing "distortion of the breast, pushing the native breast up and in." physician reports the events as being considered device related.Seri device was explanted on (b)(6) 2014, and has been returned by the physician.

Manufacturer Narrative

Allergan has received the product, however the analysis has not been completed at this time.The events of necrosis, cellulitis, irritation/inflammation, and visibility/palpability are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155 000
• Manufacturer Contact: karen herrera ; 71 s los carneros rd; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3874111
• MDR Text Key: 4462350
• Report Number: 3008374097-2014-00031
• 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: 03/25/2014

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: 07/31/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12062501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• 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: EXPLANTED ON:; IMPLANT WITH SILICONE GEL BREAST:
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR