MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542620
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/11/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.This pc is the prior event to: manufacturer report number:1645337-2020-13806.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent primary breast augmentation with a mentor siltex round moderate profile 175cc saline prosthesis experienced left sided deflation post procedure.The patient experienced major asymmetry issue due to the left deflation.As a result, replacement with cat#: 3501645, sn#: (b)(4) was performed on (b)(6) 2020.
Additional Manufacturer Narrative
On december 31, 2020 mentor became aware that the expiration date in the b5 recorded mistakenly as (b)(6) 2020.Manufacturer¿s reference number: (b)(4) the correct date of explantation is (b)(6) 2010.

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10971261
• Report Number: 1645337-2020-15585
• Device Sequence Number: 3240895
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3542620
• Device Catalogue Number: 3542620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention