MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Seroma (2069)

Event Date 10/30/2023

Event Type  Injury  

Event Description

Literature review of "complications and burden of 2-stage tissue expander to implant-based reconstructive surgery: a single-center retrospective study" reports 2 cases of rippling, 1 case of wound dehiscence, 2 cases of skin flap necrosis, 3 cases of hematoma, 12 cases of seroma, 15 cases of infection, 2 cases of asymmetry, 2 cases of te exposure, 3 cases of te failure and ¿univariate linear regression showed for every increase in bmi¿ against tissue expanders.Device was not implanted.

Manufacturer Narrative

Article citation: churchill if, gallo l, dunn e, et al.Complications and burden of 2-stage tissue expander to implant-based reconstructive surgery: a single-center retrospective study.Plastic surgery.2023;0(0).Doi:10.1177/22925503231217517.The events are a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: seroma, infection, necrosis, wound dehiscence, foreign body reaction.

• Brand Name: UNK TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18532808
• MDR Text Key: 333086269
• Report Number: 9617229-2024-01026
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female