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

Catalog Number	133MX-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	08/24/2018
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.
Event or Problem Description
Healthcare professional reported, "tissue expander appears to have white specks on it." device was not implanted.Surgery was completed with a back up device.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: it was observed that appears to be uneven texture.A leak test was performed and was not found opening.A microscopic analysis was performed which identify: the device is intact and functional.Finally, the observed variation on texture density was measure whit a eye loupe, variation measures were 2.0mm and 1.0 mm.According to allergan procedures, those variations were found within specification with the (b)(4) specification (no uneven texture area > 5 mm).Based on the device analysis the final assessment is: the device is intact and functional.Observed a variation on texture density but it is within specification.
Event or Problem Description
Healthcare professional reported, "tissue expander appears to have white specks on it." device was not implanted.Surgery was completed with a back up 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: 7901761
• Report Number: 9617229-2018-07154
• Device Sequence Number: 1552368
• Product Code: LCJ
• UDI-Device Identifier: 10888628004498
• UDI-Public: 10888628004498
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/22/2018

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: 05/05/2022
• Device Catalogue Number: 133MX-14-T
• Device Lot Number: 3209909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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