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.
Event or Problem Description
Healthcare professional reported unknown side deflation.Device has been explanted.
Event or Problem Description
Healthcare professional reported unknown side deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified yellow particles in device outer surface, flat creases, wear abrasion and one curved opening at the edge of the stable base to shell bond area on posterior 1 location.A microscopic analysis and leak test were performed which identified that the curved opening had a sharp pattern.A dimension measurement in the shell was performed which identified the thickness within specification.The measurement of the opening is 12 mm.Based on the device analysis the final assessment is an opening with a sharp pattern at the edge of stable base to shell bond area assessed as an unidentified (tear) opening.

• 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: 11301396
• Report Number: 9617229-2021-00712
• Device Sequence Number: 14294918
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: 10888628044210
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 10/01/2024
• Device Model Number: 133S-MX-15-T
• Device Catalogue Number: 133S-MX-15-T
• Device Lot Number: 3384988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/18/2021
• 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