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

Catalog Number	133MV-16-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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.Device evaluation: analysis of the returned device identified: creases flat, yellow particles and opening curved on insert assembly.Leak test and microscopic analysis was performed which identified: wear abrasion and striated opening on insert assembly.Based on the device analysis the final assessment is a striated opening on insert assembly due to surgical damage consist in the use of some surgical tool.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation is due to deflation.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Company representative reported "ruptured" device, and healthcare provider additionally reported "tissue expander which had torn at the junction of the port patch and the fluid chamber." expansion was complete.Device has been explanted.

• 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: 8681002
• Report Number: 9617229-2019-05959
• Device Sequence Number: 2354209
• Product Code: LCJ
• UDI-Device Identifier: 10888628004450
• UDI-Public: 10888628004450
• Combination Product (Y/N): N
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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: 02/14/2022
• Device Catalogue Number: 133MV-16-T
• Device Lot Number: 3175901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/07/2019
• 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