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

Catalog Number UNK TISSUE EXPANDER

Device Problems Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Cellulitis (1768); Unspecified Infection (1930)

Event Date 04/11/2023

Event Type  Injury  

Event Description

Through journal article titled "air versus saline in initial prepectoral tissue expansion: a comparison of complications and perioperative patient-reported outcomes" authors reported adverse events of "expander loss;.Seroma, hematoma, infection/cellulitis, full-thickness mastectomy skin flap necrosis (msfn) requiring revision, expander exposure, and capsular contracture" baker grade unknown in patients who had tissue expanders filled with air or saline.

Manufacturer Narrative

Continued h6: e2316 - foreign body reaction.The reported events of capsular contracture, infection, exposure, and cellulitis 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/will be requested.No additional information is available at this time.The reason for reoperation is: "expander loss;.Seroma, hematoma, infection/cellulitis, full-thickness mastectomy skin flap necrosis (msfn) requiring revision, expander exposure, and capsular contracture" baker grade unknown in patients who had tissue expanders filled with air or saline.Article citation: plotsker el, et al."air versus saline in initial prepectoral tissue expansion: a comparison of complications and perioperative patient-reported outcomes." plast reconstr surg.30 mar.2023.Doi: 10.1097/prs.0000000000010478.Epub ahead of print.Pmid: 36995181.

• Brand Name: UNK 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: 16861193
• MDR Text Key: 314470116
• Report Number: 9617229-2023-07117
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 04/11/2023
• 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