MAUDE Adverse Event Report: ABYRX INC, HEMASORB RESORBABLE BONE PUTTY; BONE WAX

Model Number OS-401

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

A distributor representative reported to abyrx that a hospital had recent problems with infections.Hemasorb had been used by this hospital during procedures since late 2014 and therefore is being taken into consideration as part of the hospital's investigation.The hospital had previously indicated difficulty cleaning their instruments following procedures involving hemasorb.The hospital believed it had corrected the issue by improving their cleaning technique.An abyrx review of the manufacturing records for all lots of hemasorb shipped to the hospital did not uncover any irregularities.No information supports a product malfunction or out of specification product.Abyrx immediately requested a telephone conversation with the surgeon or surgical coordinator, through the distributor representative, but this attempt and repeated subsequent attempts (once per week from (b)(6) 2015 to (b)(6) 2015) were unsuccessful.Unsuccessful attempts to reach hospital representatives via telephone were made on (b)(6) 2015 abd (b)(6) 2015 by abyrx.Abyrx also made unsuccessful email attempts to contact the hospital on (b)(6) 2015 and on (b)(6) 2015.Additional attempts to contact the user facility will be made.No additional information is available at this time, but will be provided as it becomes available.

• Brand Name: HEMASORB RESORBABLE BONE PUTTY
• Type of Device: BONE WAX
• Manufacturer (Section D): ABYRX INC,; irvington NY
• Manufacturer Contact: aniq darr ; 1 bridge street,ste 121; irvington, NY 10533 ; 9143572643
• MDR Report Key: 4947114
• MDR Text Key: 6256850
• Report Number: 3005972619-2015-00001
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OS-401
• Device Catalogue Number: OS-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other