MAUDE Adverse Event Report: SIENTRA INC SIENTRA SILICONE GEL BREAST IMPLANTS

Model Number 10621-XXXHP

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Capsular Contracture (1761); Nodule (4551)

Event Date 01/16/2024

Event Type  Injury  

Event Description

Right-side capsular contracture baker grade unknown and patient reported lumps in the right breast.

Manufacturer Narrative

Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANTS
• Type of Device: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 18728494
• MDR Text Key: 335708460
• Report Number: 1651189-2024-06472
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2024

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
• Device Operator: Health Professional
• Device Model Number: 10621-XXXHP
• Device Catalogue Number: 10621-440HP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/29/2024
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female