MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3505305M
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	06/02/2020
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 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: tissue expander could not be filled.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that during a breast prosthesis implantation surgery on (b)(6) 2020, a 250 cc mentor tissue expander could not be filled intraoperatively.As a result, another tissue expander was utilized without any issue.No patient consequence or adverse event was reported.
Additional Manufacturer Narrative
On july 15, 2020, the product investigation was completed.Device investigation summary: during the visual evaluation of the device and the injection reservoir, no apparent damage was observed.Leak testing was performed in accordance with mentor's procedures.No leak sites were confirmed and there were no difficulties to aerate/fill the device.Unfortunately, after a thorough analysis we were unable to confirm your reported event.If you feel this needs to be submitted for additional review, please provide any additional supporting documentation for review.(i.E., device photos, videos).Please confirm the correct device was returned in the pre-labeled return kit.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10195820
• Report Number: 1645337-2020-07791
• Device Sequence Number: 3297574
• Product Code: LCJ
• UDI-Device Identifier: 00081317002581
• UDI-Public: 00081317002581
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 08/18/2023
• Device Model Number: 3505305M
• Device Catalogue Number: 3505305M
• Device Lot Number: 9359137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1