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

Catalog Number	133MX-14-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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.The event of symmastia is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: ¿i have no cleavage line, its just one big boob.I've been having sharp pain." further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported ¿i have no cleavage line, its just one big boob.I've been having sharp pain." device remains implanted.Unknown side.

• Brand Name: STYLE 133MX 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: 9033371
• Report Number: 9617229-2019-13977
• Device Sequence Number: 2117304
• Product Code: LCJ
• UDI-Device Identifier: 10888628004498
• UDI-Public: 10888628004498
• Combination Product (Y/N): N
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 12/24/2019
• Device Catalogue Number: 133MX-14-T
• Device Lot Number: 2857065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/13/2019
• 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: Required Intervention