MAUDE Adverse Event Report: ALLERGAN ALLODERM TISSUE EXPANDER

Lot Number RH116017-011

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Received a phone call from the operating room, this pt had previously had bilateral breast implant placed with tissue expanders, which was completed at another facility.Pt presented to our facility or surgery to remove the right tissue expander due to possible defect.The expander had been saved to be returned to the company.Obtained package info from other facility's risk department to complete a medwatch.Lifecell corp.(b)(4).

• Brand Name: ALLODERM TISSUE EXPANDER
• Type of Device: TISSUE EXPANDER
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 6173638
• MDR Text Key: 62468296
• Report Number: MW5066689
• Device Sequence Number: 1
• Product Code: LCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Lot Number: RH116017-011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4); ALLERGAN TISSUE EXPANDER 600CC, STYLE 133 MV,; ALLODERM READY TO USE CONTOUR LARGE PERFORATED-; THICK, LOT #RH116017-011, REF # (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100