MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-11-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-11-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Foreign Body Sensation in Eye (1869); Failure of Implant (1924); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The events of "exposure, wound dehiscence, and infection" are a physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: exposure, wound dehiscence, and infection (late onset).
Event or Problem Description
Healthcare professional reported left side "infected tissue expander".Additionally, healthcare professional reported wound dehiscence and exposure.Device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.In response to fda report number: 0800040000- 2020-80 30.
Event or Problem Description
Healthcare professional indicated that the events of wound dehiscence and exposure were not due to or caused by the device; "uncertain etiology" noted as cause.Additionally, healthcare professional reported via regulatory agency left side "rupture" and hematoma.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-11-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10587007
• Report Number: 9617229-2020-15401
• Device Sequence Number: 16436116
• Product Code: LCJ
• UDI-Device Identifier: 10888628044173
• UDI-Public: 10888628044173
• Combination Product (Y/N): N
• Initial Reporter State: DE
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 10/12/2024
• Device Model Number: 133S-MX-11-T
• Device Catalogue Number: 133S-MX-11-T
• Device Lot Number: 3389149
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 03/10/2021
• 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