MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS FV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	133P-FV-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: preliminary product examination: prior to use, examine the tissue expander for leakage by partially filling with sterile saline for injection and gently compressing.To avoid missing any leaks due to hand position, reposition the tissue expander several times and repeat the inspection.If satisfactory, aspirate all sterile saline and air from the inspected tissue expander, return the expander to the inner thermoform tray and cover it with the lid until implanted to prevent contact with airborne contaminants.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.Do not attempt to repair damaged products.
Event or Problem Description
Healthcare professional reported a dislodged port in a tissue expander.Implant surgery was successfully completed with a backup device.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: white particle.Leak test was performed and no leakage was found.Based on the device analysis the final assessment is during the analysis nothing was observed to be dislodged, nor port leak, or damage on the device.Leak test was performed and no leakage was found during analysis additional.
Event or Problem Description
Healthcare professional reported a dislodged port in a tissue expander.Implant surgery was successfully completed with a backup device.

• Brand Name: STYLE 133PLUS FV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7067229
• Report Number: 9617229-2017-04819
• Device Sequence Number: 10788632
• Product Code: LCJ
• UDI-Device Identifier: 10888628009707
• UDI-Public: (01)10888628009707(10)2935562(11)160716(17)210616
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 06/16/2021
• Device Catalogue Number: 133P-FV-14
• Device Lot Number: 2935562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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
• Patient Age: 70 YR