MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Catalog Number	133MX-12-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare provider reported right side "expander, filled to 350- 5 days after surgery patient said the expander started to leak.He didn¿t do any office fill." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening, black mold.Leak test was performed and found opening on posterior.A microscopic analysis was performed which identify a striated edge opening in the stable base side, consist with use of a surgical tool.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is a striated edge opening on stable base side due to surgical damage.
Event or Problem Description
Healthcare provider reported right side "expander, filled to 350- 5 days after surgery patient said the expander started to leak.He didn't do any office fill." device has been explanted.

• Brand Name: STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8397188
• Report Number: 9617229-2019-01304
• Device Sequence Number: 2765268
• Product Code: LCJ
• UDI-Device Identifier: 10888628004474
• UDI-Public: 10888628004474
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 07/17/2022
• Device Catalogue Number: 133MX-12-T
• Device Lot Number: 3238711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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