MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SALINE SMOOTH ROUND MODERATE PROFILE IMPLANTS; BREAST IMPLANT

Catalog Number	350-1640
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) review is in progress.Once completed, the information will be submitted in a supplemental.This complaint is related to the other mdr for the other implant on the same patient: (b)(4).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a female patient (age: unk) underwent a breast cosmetic surgery with mentor saline implants in (b)(6) 2001.Recently she had implants explantation for unknown reason.During explantation, the physician observed mold in devices.No further information is available at present.
Additional Manufacturer Narrative
An attempt was made to submit this report on 09/20/2017.However, due to an outage affecting the esg or the cdrh emdr processing system we were unable to meet the report submission due date.(b)(4).
Additional Manufacturer Narrative
This supplemental report is to provide dhr.The device history record (dhr) of lot number 223220 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
Device investigation summary: since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Manufacturing controls: the manufacturing process (from shell fabrication to secondary packaging) was reviewed for foreign matter/ particulate control at mentor irving cmes (controlled manufacturing environment) which includes shell fabrication, main assembly, primary packaging areas, gamma sterilization, and secondary packaging areas.At multiple points of the manufacturing process, devices within the lot are processed to ensure any foreign matter, particulates or contaminants are removed or 100% visually inspected for any defects including foreign matter or particulates and subsequently rejected when identified.All manufacturing areas where the shell or device is exposed to environment is a controlled manufacturing environment (cme).Gowning is required and strictly enforced for all individuals entering designated controlled manufacturing environments (cme) at mentor, whether they are mentor employees, visitors or contractors.The cme garments consist of hair coverings (bouffant and/or hood), frock or jumpsuit, and shoe or boot covers.Sterilization records were also reviewed for product code 350-1640, lot# 223220.Environmental monitoring for viable airborne particulates and surface microbials is routinely performed in each controlled manufacturing environment (cme) on a weekly basis.Review of the environmental monitoring data for viable airborne particulates and surface microbials during the manufacturing of product code 350-1640, lot# 223220 identified all acceptable results in order to release the lot.Non-viable particulates are measured on a quarterly basis.Review of the non-viable particulates data for q204 and q304 (periods before and after the manufacture of product code 350-1640, lot# 223220) were reviewed and no excursions were identified.A root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.Infection is a known complication associated with any surgery.The application failure modes and effects analysis (afmea) was reviewed for the defect in question (foreign matter/mold) with hazard risk was determined to be as low as possible (alap), with no further action required.If the complaint device is received in the future, the complaint will be re-opened and additional investigation will be completed.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SALINE SMOOTH ROUND MODERATE PROFILE IMPLANTS
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6884038
• Report Number: 1645337-2017-00108
• Device Sequence Number: 2016825
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/21/2017

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 Expiration Date: 02/15/2005
• Device Catalogue Number: 350-1640
• Device Lot Number: 223220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 08/21/2017; 02/28/2019
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/09/2017; 10/11/2017; 03/30/2019
• 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: Other; Required Intervention