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

Catalog Number	NON MENTOR
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Code Available (3191)
Date of Event	05/01/2016
Type of Reportable Event	Malfunction
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent an unspecified procedure with mentor cpx 2 breast tissue expanders 350cc and experienced sickness, loss of movement on the right side, neck pain, back pain, and deflation on the right side.The deflation was discovered during explantation on (b)(6) 2019.It is unknown which side each device corresponds to.This report has been defaulted to the right side.If additional information is received regarding device information, a supplemental will be submitted.
Additional Manufacturer Narrative
Additional information was received on 9/4/2019 indicating the complaint device was a non-mentor product.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).

• Brand Name: NON MENTOR PRODUCT
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8795158
• Report Number: 1645337-2019-15421
• Device Sequence Number: 1978216
• Product Code: LCJ
• UDI-Device Identifier: 00081317002253
• UDI-Public: 00081317002253
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2019

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: 08/31/2016
• Device Catalogue Number: NON MENTOR
• Device Lot Number: 6619890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 09/04/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/28/2019; 09/17/2019
• 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: Required Intervention
• Patient Age: 46 YR