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

Catalog Number	133MV-13-T
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported "when the item was opened the top layer of the white covering was not attached causing the implant to fall out on the floor".The device was not implanted.It is unknown if surgery was completed with a back-up device.

• Brand Name: STYLE 133MV 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: 8273717
• Report Number: 9617229-2019-00211
• Device Sequence Number: 1557404
• Product Code: LCJ
• UDI-Device Identifier: 10888628004429
• UDI-Public: 10888628004429
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 09/12/2022
• Device Catalogue Number: 133MV-13-T
• Device Lot Number: 3264052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/24/2019
• 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