25-10014 NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-11-27 for 25-10014 NI manufactured by Santa Barbara.

Event Text Entries

[547332] Reported as pain, scarring and extrusion after placement of facial chin implant. Further clarification of the event per the explanation op report: incipient extrusion and asymmetry of chin implant. Additionally scar contracture of the implant was released and removed along with the chin implant.
Patient Sequence No: 1, Text Type: D, B5

[7914403] Device labeling: patients should be advised that medical management of adverse reactions may include explantation. Explantation and replacement may also be indicated to achieve patient satisfaction. Patients should be informed that dissatisfying cosmetic results such as scar deformity, hypertrophic scarring, asymmetry, displacement, incorrect size, unanticipated contour or projection, transillumination, and palpalbility may occur. Careful preoperative planning and surgical technique are essential to minimize the occurrence of such results. Implant extrusion, or exposure, may occur and require removal, result in disfigurement, and require revision surgery. Predisposing factors include inadequate tissue covering, inadequate surgical pocket size, unsuitably large implant, displacement, and associated necrosis. As expected following any invasive surgical procedure, pain of varying intensity and duration will occur following facial implantation. In addition, improper size, placement, or surgical technique may result in pain associated with nerve entrapment or interference with muscle motion. Pain may also accompany other adverse reactions. Unexplained pain must be promptly investigated. Additional device labeling: formation of a fibrous tissue capsule is a normal physiologic response to any foreign body, including silicone facial implants. The smooth capsule often improves implant immobility and facial contour. Contracture of the fibrous tissue capsule around silicone facial implants has not been reported as a complication in the literature, but could potentially result in firmness, implant displacement, discomfort or pain.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2024601-2006-00672
• MDR Report Key: 788244
• Report Source: 00
• Date Received: 2006-11-27
• Date of Report: 2006-10-30
• Date of Event: 2002-04-02
• Date Mfgr Received: 2006-10-30
• Date Added to Maude: 2006-12-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: TIM KIRKELIE
• Manufacturer Street: 700 WARD DR
• Manufacturer City: SANTA BARBARA CA 93111
• Manufacturer Country: US
• Manufacturer Postal: 93111
• Manufacturer Phone: 8006244261
• Manufacturer G1: SANTA BARBARA
• Manufacturer Street: 71 S. LOS CARNEROS
• Manufacturer City: GOLETA CA 93111
• Manufacturer Country: US
• Manufacturer Postal Code: 93111
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 25-10014
• Generic Name: FACIAL IMPLANT
• Product Code: JAZ
• Date Received: 2006-11-27
• Model Number: NI
• Catalog Number: 25-10014
• Lot Number: 2-136298
• ID Number: P08-RA0011
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 775981
• Manufacturer: SANTA BARBARA
• Manufacturer Address: 71 SOUTH LOS CARNEROS GOLETA CA 93117 US
• Baseline Brand Name: 25-10014
• Baseline Generic Name: FACIAL IMPLANT
• Baseline Model No: NI
• Baseline Catalog No: 25-10014
• Baseline ID: P08-RA0011

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-11-27