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

Catalog Number	133MX-11-T
Medical Device Problem Code	Flaked (1246)
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.Device evaluation: the device related to broken device ("outer shell was flaking off") event was received on apr 24, 2018, with lot number: 3005638.Visual analysis of the returned device observed no damage on the shell of the device.A leak test was performed which identified no openings on the device.Microscopic analysis was performed which identified "outer shell was flaking off" was not observed.Based on the device analysis the final assessment is: - no issues found related with the manufacturing process.- the ¿outer shell was flaking off¿ was not observed, for this reason the reported event cannot be confirmed.- device found intact and functional.Device labeling: do not implant any device that appears to have particulate contamination, nicks or leaks.A sterile back-up tissue expander must be readily available at the time of surgery.
Event or Problem Description
Healthcare professional reported a tissue expander's "outer shell was flaking off".Surgery was successfully completed with a backup 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: 7506532
• Report Number: 9617229-2018-03420
• Device Sequence Number: 1862373
• Product Code: LCJ
• UDI-Device Identifier: 10888628004467
• UDI-Public: 10888628004467
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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

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: 12/10/2020
• Device Catalogue Number: 133MX-11-T
• Device Lot Number: 3005638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: Other