MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR MEMORYGEL XTRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	THPX765
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a hair like substance was found on mentor memorygel xtra, siltex high profile, 765cc.No patient contact or consequences reported.
Additional Manufacturer Narrative
On 3/9/2019, the manufacturing record evaluation (mre)) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary upon receipt by mentor, the gel contained in the device appears clear.No foreign material was observed within the device.Grey material was observed on the shell surface.Upon initial inspection the device appears intact.No other anomalies were discovered.The product was returned, and no hair was observed, however grey material, like fiber from absorbent material, was observed.Ft-ir results revealed that foreign material is primarily composed of polypropylene-base material, the potentially source of origin presumably was the absorbent packing material.Complaint was not confirmed since no hair was found on the device returned.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 8271968
• Report Number: 3006942524-2019-00504
• Device Sequence Number: 1234372
• Product Code: FTR
• UDI-Device Identifier: 00081317025801
• UDI-Public: 00081317025801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2023
• Device Catalogue Number: THPX765
• Device Lot Number: 7596016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/09/2019; 03/21/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/11/2019; 03/22/2019
• Patient Sequence Number: 1