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 Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

The event of "exposure" is 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: exposure.

Event Description

Healthcare professional reported for an unknown side "te exposed case o-22-2 reconstruction option and brca examination¿ was reported: ¿another case, risk-reducing mastectomy and sbi reconstruction were planned after breast-conserving therapy, but patient was changed to ld reconstruction because her te on the conserving therapy side was about to be exposed.¿ device status is unknown.

• 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: 15856988
• MDR Text Key: 304230194
• Report Number: 9617229-2022-21126
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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: 11/01/2022
• 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