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); Pain (1994); Insufficient Information (4580)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device discarded.

Event Description

Pain and tightness of both implants and unspecified symptoms.

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Correction: b5 h3 other text : device discarded.

Event Description

Bilateral capsular contracture, baker grade 2, right side; pain and tightness of both implants and unspecified symptoms.

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

Bilateral capsular contracture, baker grade unknown, right side; pain and tightness of both implants and unspecified symptoms.

• 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: 18230744
• MDR Text Key: 329277925
• Report Number: 1651189-2023-05982
• 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,Followup
• Report Date: 11/28/2023

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: 10621-XXXHP
• Device Catalogue Number: 10621-415HP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/28/2023
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 12/06/2023
• Supplement Dates FDA Received: 12/06/2023; 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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: 64 YR
• Patient Sex: Female