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

Model Number 133S-MX-11-T

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Manufacturer Narrative

Gt hold 9 28 concomitant of medical products: lot rh 217299-010, expiration 2021-12.Reference (b)(4) 16 x 20 cm perforated thick, date of therapy: (b)(6).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 events of "wound dehiscence, exposure, and infection" are 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: "infection due to wound dehiscence and exposure".

Event Description

Hospital sales representative reported " revision is the result of removal of an infected tissue expander." healthcare provider also reported ¿wound dehiscence and exposure".Device has been explanted.This record is for the right side.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10590605
• MDR Text Key: 208705606
• Report Number: 9617229-2020-15402
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10888628044173
• UDI-Public: 10888628044173
• Combination Product (y/n): N
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 3353236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention