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

Catalog Number	133P-MV-14
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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 needle puncture or other damage to the tissue expander or the injection site during the expansion process.
Event or Problem Description
Healthcare professional reported a tissue expander that was found to be pierced upon implant surgery.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: white particles in shell, no openings were found.A leak test was performed which did not identify openings on the device.Microscopic analysis was performed which did not identify any additional observations.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.No openings were found on the device and found no possible damage on valve, for this reason lab could not confirm the complaint (broken device).Intact and functional.
Event or Problem Description
Additionally health professional reported "the implant was pierced and therefore not used at all - seen during unpacking.Surgery was completed with a back-up device, and the device did not come into contact with the patient.".

• Brand Name: STYLE 133PLUS MV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6831068
• Report Number: 9617229-2017-02215
• Device Sequence Number: 11163052
• Product Code: LCJ
• UDI-Device Identifier: 10888628010062
• UDI-Public: (01)10888628010062(10)3030382(11)170315(17)220215
• 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): 12/04/2017

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: 02/15/2022
• Device Catalogue Number: 133P-MV-14
• Device Lot Number: 3030382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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: 57 YR