MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133 TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number UNK STYLE 133

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: zip code:(b)(6).The events of "corner of te reached the skin and bedsore presented" 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: "bending of te [tissue expander]," and "corner of te reached the skin and bedsore presented.".

Event Description

Healthcare professional reported unspecified side "bending of te [tissue expander]," and "corner of te reached the skin and bedsore presented." device was explanted and "replaced with imp.".

• Brand Name: STYLE 133 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 12025178
• MDR Text Key: 257271537
• Report Number: 9617229-2021-46949
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STYLE 133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• 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