MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3541258
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.For lot 6750182: 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.For lot 6755946: a manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient who underwent primary breast augmentation with two 315cc mentor memoryshape breast implants, suffered unilateral capsular contracture; baker grade iii on an unspecified side, post-procedure.The capsular contracture was diagnosed by a doctor.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.The following lot numbers and serial numbers were provided but it was not specified which breast had the capsular contracture: (left: catalog: 3541258 lot: 6750182 sn: (b)(4) and right: catalog: 3541258 lot: 6755946 sn: (b)(4)).Follow-ups were performed but no information was received.If clarification is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
Mentor became aware that the device manufacturing date and expiration date for lot number: 6750182 were erroneously omitted in the initial report sent on july 31, 2020.The dates are the following (manufacturing date: 08/22/2013, expiration date: 08/31/2018).For lot: 6755946: 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.(manufacturing date: 09/09/2013, expiration date: 09/30/2018).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10353012
• Report Number: 1645337-2020-09472
• Device Sequence Number: 2432327
• Product Code: FTR
• UDI-Device Identifier: 00081317005469
• UDI-Public: 00081317005469
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: Health Professional
• Device Model Number: 3541258
• Device Catalogue Number: 3541258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: Other
• Patient Age: 33 YR