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

Catalog 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	05/31/2018
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.Device labeling: extreme care should be taken to avoid damage to the tissue expander during surgery.Possible sources of damage include sharp surgical instruments such as scalpels and needles used during the initial surgery, subsequent filling, or hematoma/fluid evacuation.A sterile back-up tissue expander must be readily available at the time of surgery in the event that damage occurs.Products must be carefully inspected for leaks or nicks prior to use.Do not attempt to repair damaged products.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 "a hole" on the tissue expander and was not implanted.

• 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: 7632505
• Report Number: 9617229-2018-05023
• Device Sequence Number: 11151749
• Product Code: LCJ
• UDI-Device Identifier: 10888628004306
• UDI-Public: 10888628004306
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: 133FX-13-T
• Device Lot Number: 3103483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/23/2018
• 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