MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS SMOOTH; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542915
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with mentor smooth round saline implants 700cc and experienced generalized illness symptoms.The patient suffered from chest pain, sleeping issues, issues with swallowing foods, stomach issues, migraines, eyes swell, skin rashes.The patient has a history of bilateral hypomastia.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch is for the right breast implant.
Additional Manufacturer Narrative
On 5/29/2020, it was reported to mentor that the patient experienced nodule on thyroid, lump in cheek, throat has a sac in it, issues with sinuses.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 1/16/2020, it was reported to mentor that the date of birth was (b)(6) 1975 and the date of implantation was (b)(6) 2004.The procedure was breast augmentation.The pain is mostly on the right side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 7/31/2020, it was reported to mentor that the date of implantation was (b)(6) 2004.The patient was diagnosed with bilateral hypomastia.The implanted implants were mentor smooth round saline implants 700cc.The patient was 28 years old.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 8/25/2021, it was reported to mentor that the date of removal is (b)(6) 2022 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, mentor received additional information about the event.The patient did not receive replacement breast prostheses after removal surgery on (b)(6) 2022.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANTS SMOOTH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9590862
• Report Number: 1645337-2020-00831
• Device Sequence Number: 3012497
• Product Code: FWM
• UDI-Device Identifier: 00081317001898
• UDI-Public: 00081317001898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/26/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3542915
• Device Catalogue Number: UNK_SALINE IMPLANTS SMOOTH
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 05/29/2020; 07/31/2020; 08/25/2021; 01/05/2022
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/17/2020; 06/10/2020; 08/03/2020; 08/27/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female