MAUDE Adverse Event Report: MENTOR TEXAS, LLC; TISSUE EXPANDERS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Swelling (2091); Skin Inflammation (2443)

Event Type  Injury  

Event Description

(b)(6) reports pt was implanted w/ tissue expanders and formed a red rash that proceeded to turn into blisters.Pt has been diagnosed by a dermatologist as having dermatitis.

• Type of Device: TISSUE EXPANDERS
• Manufacturer (Section D): MENTOR TEXAS, LLC; irving TX 75038
• Manufacturer Contact: christy babb ; 3041 skyway circle north; irving, TX 75038 ; 9722526060
• MDR Report Key: 5130851
• MDR Text Key: 27648616
• Report Number: 1645337-2015-00182
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other