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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2019
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 professional reported to company representative a "small blond hair on top of the expander." patient contact did not occur and surgery was completed with a backup device.
Event or Problem Description
Healthcare professional reported to company representative a "small blond hair on top of the expander." patient contact did not occur and surgery was completed with a backup device.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified device appearance (no observed blond hair on top of the expander).Leak test was performed, and no leakage was found.A microscopic analysis was performed which identified no openings observed in the device, the fill test inspection was performed with the result of no blockage.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.No hair or fiber is seen in the device.

• 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: 8526883
• Report Number: 9617229-2019-02513
• Device Sequence Number: 13920916
• Product Code: LCJ
• UDI-Device Identifier: 10888628004474
• UDI-Public: 10888628004474
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 09/05/2022
• Device Catalogue Number: 133MX-12-T
• Device Lot Number: 3261096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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