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

Model Number	SMXP135RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.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: wound infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent unspecified breast reconstruction surgery with 500cc artoura breast tissue expander and experienced wound infection on her left side postoperatively.The patient underwent bilateral explantation and replacement with catalog number smxp135rh; serial number (b)(4) on the left side and with catalog number smxp135rh; serial number (b)(4) on the right side on (b)(6) 2019.
Additional Manufacturer Narrative
On 5/20/2020, mentor became aware of the following: 1) patient's age was 53; field a2 has been updated on this form 2) this was patient's primary reconstruction surgery 2) date of explant was updated to (b)(6) 2019 under field d7 as per additional information received, removal of the left implant for (b)(6) was (b)(6) 2019 and no replacement until (b)(6) 2020 with catalog number smxp135rh; serial number (b)(6) on the left side.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10070265
• Report Number: 1645337-2020-06348
• Device Sequence Number: 766010
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 05/05/2023
• Device Model Number: SMXP135RH
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7713762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/02/2020
• 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
• Patient Age: 43 YR