MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	133MV-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Hcp reported a right side tissue expander magnet was "free-floating within implant." device was explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: opening curved on anterior and device appearance (observed the needle guard dislodged) leak test and microscopic analysis was performed which identified: striated opening on anterior and device appearance.Reason for reoperation reported as "tissue expander magnet was "free-floating within implant".
Event or Problem Description
Hcp reported a right side tissue expander magnet was "free-floating within implant." device was explanted.

• Brand Name: STYLE 133MV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8543865
• Report Number: 9617229-2019-02879
• Device Sequence Number: 13544937
• Product Code: LCJ
• UDI-Device Identifier: 10888628004139
• UDI-Public: 10888628004139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2022
• Device Catalogue Number: 133MV-14
• Device Lot Number: 3200250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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: 38 YR