MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
|
Back to Search Results |
|
Catalog Number 3503254BC |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problem
Capsular Contracture (1761)
|
Event Date 02/09/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: capsular contracture.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).
|
|
Event Description
|
It was reported that a patient who underwent breast augmentation with mentor memorygel breast implants experienced bilateral baker grade iii capsular contracture post procedure.As a result, explant was performed on (b)(6) 2024.See 1645337-2024-03669 for contralateral prosthesis report.
|
|
Manufacturer Narrative
|
The impacted product was received by the failure analysis lab on april 11, 2024.The investigation of the returned device was completed by the failure analysis lab on april 17, 2024.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|