MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNKNOWN SALINE IMPLANTS

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Since the device has not been returned for analysis, 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 manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) year old caucasian female patient underwent a primary breast augmentation with unknown saline breast implants which the right side deflated after implantation.As a result patient scheduled for removal on (b)(6) 2019.

Manufacturer Narrative

Device received on (b)(6) 2019 device evaluation completed on (b)(6) 2019 during evaluation of the sample it was noticed a tear in the anterior and extending to the posterior view, measuring approximately 3.0 cm.Leak testing was performed in accordance with mentor procedures and no other leak sites were detected.Microscopic examination of the edges of the rupture revealed parallel striations.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 2/20/2020, additional information received indicated that the patient underwent bilateral removal and replacements as follow: right replaced with cat#:3501635, sn#:(b)(6) and left replaced with cat#:3501635, sn#: (b)(6).Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8823834
• MDR Text Key: 152113142
• Report Number: 1645337-2019-15874
• Device Sequence Number: 1
• Product Code: FMW
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN SALINE IMPLANTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 02/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR