MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.Reason for reoperation: deflation.Device evaluation: yellow particles device inner surface and one curved opening.A microscopic analysis and leak test were performed which identified three openings striated.Based on the device analysis the final assessment is: three openings striated in the side suture tap/radius assessed as surgical damage.
Event or Problem Description
Healthcare professional reported right side deflation.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-15-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 12599143
• Report Number: 9617229-2021-54129
• Device Sequence Number: 14251438
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: 10888628044210
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: 09/16/2024
• Device Model Number: 133S-MX-15-T
• Device Catalogue Number: 133S-MX-15-T
• Device Lot Number: 3381270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/08/2021
• 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