MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) RND RE-STER SIZER 10, 150; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ10150
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
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.The reason for reoperation: patient's concern with the product, this device is a resterilizable sizer and not meant to be implanted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported patient's concern with the product.Additionally, this device is a resterilizable sizer and not meant to be implanted.Affected side is unknown.The device has been explanted.

• Brand Name: RND RE-STER SIZER 10, 150
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10784964
• Report Number: 9617229-2020-17921
• Device Sequence Number: 2908417
• Product Code: MRD
• UDI-Device Identifier: 10888628005518
• UDI-Public: 10888628005518
• Combination Product (Y/N): N
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 10/09/2020
• Device Catalogue Number: MSZ10150
• Device Lot Number: 2826388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 89