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

Catalog Number	133MV-14-T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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 "plastic seems wet, and something brownish is on the inside as well".Device was not implanted.
Additional Manufacturer Narrative
Reason for reoperation is not applicable as device was not implanted.Visual analysis of the returned device identified; device appearance (a wet plastic was observed, and the outer box is dye brown).However, a further investigation will be requested to analyze this case.Based on the device analysis the final assessment is a wet plastic was observed, and the outer box is dye brown.
Event or Problem Description
Healthcare professional reported "plastic seems wet, and something brownish is on the inside as well." device was not implanted.
Additional Manufacturer Narrative
Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices with the work order were released in accordance with allergan medical¿s procedures, and no anomalies were found in the documents or in the personnel training related to the reported event.Review of all complaints for the period of apr 2017 through mar 2019 related with mfg date and found no adverse trend in the event rate with respect to the reported event.According to the device analysis performed in the laboratory, the reported event of ¿plastic seems wet and something brownish is on the inside¿ was identified.An investigation was realized, the root cause of the event couldn't be determine, however, i was confirmed that each unit are inspected several times.Considering that there is not an adverse trend for this type of event no additional actions are deemed required at this time.The issue with shrink wrap damage (wet plastic and brown stain) will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported "plastic seems wet, and something brownish is on the inside as well." device was not implanted.

• Brand Name: STYLE 133MV 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: 8466589
• Report Number: 9617229-2019-01872
• Device Sequence Number: 1341489
• Product Code: LCJ
• UDI-Device Identifier: 10888628004436
• UDI-Public: 10888628004436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/12/2019

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: 06/04/2021
• Device Catalogue Number: 133MV-14-T
• Device Lot Number: 3072246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 05/20/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/09/2019; 06/12/2019
• 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; Required Intervention