MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN GEL IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number UNKNOWN GEL IMPLANTS

Device Problem Degraded (1153)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a (b)(6)-year old female patient underwent primary breast augmentation with unknown gel breast prostheses.Patient reported pain, on and off throbbing pinch/slight burn and itching.Mri showed degeneration.At the time of this report, mentor has received no information regarding explantation or explantation date.

• Brand Name: UNKNOWN GEL IMPLANTS
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-868
• MDR Report Key: 7390621
• MDR Text Key: 104131065
• Report Number: 1645337-2018-01891
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR