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

Catalog Number UNK CUI TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Necrosis (1971)

Event Type  Injury  

Event Description

Japanese breast cancer society reported 33 cases of "nipple areolar necrosis", "skin necrosis at the incision site or skin flap", "te exposure from the skin necrosis site", "wound dehiscence", "replaced due to upper deviation of the implant", "pain or discomfort" and "postoperative hemorrhage/hematoma".Devices placement are unknown.

Manufacturer Narrative

The events of hemorrhage, wound dehiscence , necrosis and exposure are 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: hemorrhage, wound dehiscence , necrosis and exposure.

• Brand Name: UNK CUI TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17383157
• MDR Text Key: 319738109
• Report Number: 9617229-2023-12459
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K865056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CUI TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2023
• 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