MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SRM-685
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture, pain, urticaria, allergic reaction/hypersensitivity, visibility/palpability, pain-ndr, lump/nodule-ndr.
Event or Problem Description
Patient reported left side "discomfort when sleeping, broke out in hives (face, arms), sun sensitivity, and experienced indentation." patient also reported "joint pain and nodule on nipple" which are not device related.Patient later reported rupture.Device remains implanted.
Event or Problem Description
Patient reported, left side "discomfort when sleeping, broke out in hives (face, arms), sun sensitivity and experienced indentation".Patient also reported, "joint pain and nodule on nipple".Which are not device related.Patient later reported, rupture.Device remains implanted.
Additional Manufacturer Narrative
Date of occurrence: (b)(6) 2024.
Event or Problem Description
Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ urticaria: unable to observe.¿ pain: unable to observe.¿ allergic reaction/hypersensitivity: unable to observe.¿ lump-nodule-ndr: unable to observe.¿ pain-ndr: unable to observe.¿ visibility/palpability: unable to observe.¿ rupture: observed a broken assessed as an unidentified (tear) opening (shell thickness within spec) and missing shell observed assessed as inconclusive.No other observations observed, no further actions are required.
Event or Problem Description
Patient reported left side "discomfort when sleeping, broke out in hives (face, arms), sun sensitivity, and experienced indentation." patient also reported "joint pain and nodule on nipple" which are not device related.Patient later reported rupture.Device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19018910
• Report Number: 9617229-2024-0011218
• Device Sequence Number: 7993950
• Product Code: FTR
• UDI-Device Identifier: 10888628007208
• UDI-Public: 10888628007208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: SRM-685
• Device Lot Number: 3185101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 07/31/2024; 09/24/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/12/2024; 08/22/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2018
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 97 KG