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

Catalog Number	133MX-16-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.The reason for reoperation was tissue expander leak.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported tissue expander was "leaking from the safe zone." device has been explanted.This record is for the left side.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: black mold like appearance and opening curved on anterior leak test and microscopic analysis was performed which identified: striated punctured on anterior, striated opening on anterior and striated punctured on insert.Based on the device analysis the final assessment is: a striated opening on anterior due to surgical damage consist in the use of some surgical tool.A striated punctured on anterior and insert assembly due to surgical damage like consist in the use of some surgical tool.A sharp opening on suture tab due to an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported tissue expander was "leaking from the safe zone." device has been explanted.This record is for the left side.

• 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: 8951026
• Report Number: 9617229-2019-11127
• Device Sequence Number: 16762054
• Product Code: LCJ
• UDI-Device Identifier: 10888628004511
• UDI-Public: 10888628004511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/20/2019

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: 10/23/2022
• Device Catalogue Number: 133MX-16-T
• Device Lot Number: 3278155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: Other