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

Model Number	133FX-13-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
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 analysis results: the device related to the reported event of broken device received on august 18, 2017 with lot number 3039271.Visual analysis of the returned device found no openings.A leak test was performed and found no leakage.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.Device labeling: "extreme care should be taken to avoid needle puncture or other damage to the tissue expander or the injection site during the expansion process.".
Event or Problem Description
Healthcare professional reported "tissue expander was leaking" during implantation surgery.Patient contact with the device did occur.Surgery was completed with a back up device.

• Brand Name: STYLE 133FX 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: 6829699
• Report Number: 9617229-2017-02104
• Device Sequence Number: 19210346
• Product Code: LCJ
• UDI-Device Identifier: 10888628004306
• UDI-Public: (01)10888628004306(10)3039271(11)170407(17)210307
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 03/07/2021
• Device Model Number: 133FX-13-T
• Device Catalogue Number: 133FX-13-T
• Device Lot Number: 3039271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/30/2017
• 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
• Patient Age: 61 YR