MAUDE Adverse Event Report: HYGEIA II MEDICAL GROUP INC. HYGEIA FLANGE

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 09/11/2015

Event Type  Injury  

Manufacturer Narrative

The customer service representative troubleshooted with the customer at the date of the event and found that the pump sounded fine, and the piece of plastic on the flange assembly located inside the flange assembly just above the part where the tubing is attached had a piece of plastic sticking out.The customer service representative sent complimentary flanges to the customer.The customer was also referred to go see a location consultant to have the flange size checked.On (b)(6) 2015, the customer service representative contacted the customer to follow-up with the flanges that the customer service representative had sent the customer.The customer was happy about the flanges that the customer service representative had sent the customer, and the customer stated that the customer did not have any issues or concerns.

Event Description

Customer contacted our customer service representative on (b)(6) 2015 stating that there was a nick in the plastic on the inside of one of the flanges.The flange got caught on the customers skin, causing the customer to bleed.The customer stated that the customer felt a rough spot on the flange a couple days prior to the date of the event.

• Brand Name: HYGEIA FLANGE
• Type of Device: FLANGE
• Manufacturer (Section D): HYGEIA II MEDICAL GROUP INC.; 6005 hidden valley rd ; suite 230; carlsbad CA
• Manufacturer Contact: john gherman ; 6005 hidden valley rd; suite 230; carlsbad, CA 92011 ; 7145157571
• MDR Report Key: 5150187
• MDR Text Key: 28366512
• Report Number: 3006774448-2015-00002
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: NA
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other