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

Model Number 20676-XXXU

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Breast Discomfort/Pain (4504); Insufficient Information (4580)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).Investigational device [ide], no expiration date or date of manufacture available.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.

Event Description

Left-side malposition and bilateral breast pain, left side.

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra received the suspected device from the customer and performed a failure analysis.The device was returned intact and functional with light yellowing; creases were observed.No additional observations.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: 17541702
• MDR Text Key: 321080346
• Report Number: 1651189-2023-05336
• 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,Followup
• Report Date: 08/11/2023

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: 20676-XXXU
• Device Catalogue Number: 20676-305U
• Device Lot Number: 1860347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/11/2023
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female