MAUDE Adverse Event Report: ALLERGAN STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number N/A

Device Problem Device Expiration Issue (1216)

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

Event Date 01/30/2015

Event Type  malfunction  

Event Description

Sales representative reported that an expired silicone gel device was delivered to a physician and successfully implanted into a patient.The device remains implanted.No injury was reported.

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

• Brand Name: STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane suite 100; austin, TX 78753 ; 8132638
• MDR Report Key: 4912011
• MDR Text Key: 6052979
• Report Number: 9617229-2015-00226
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2015
• Device Model Number: N/A
• Device Catalogue Number: 115-547
• Device Lot Number: 1811362
• Other Device ID Number: (01)10888628002456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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