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

Model Number 133S-MX-11-T

Device Problems Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Foreign Body Sensation in Eye (1869); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

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 Description

Healthcare professional reported left side "infected tissue expander".Additionally, healthcare professional reported wound dehiscence and exposure.Device has been explanted.

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 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
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10587007
• MDR Text Key: 208550015
• Report Number: 9617229-2020-15401
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10888628044173
• UDI-Public: 10888628044173
• Combination Product (y/n): N
• PMA/PMN Number: K182054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 133S-MX-11-T
• Device Catalogue Number: 133S-MX-11-T
• Device Lot Number: 3389149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention