MAUDE Adverse Event Report: BAXTER APATECH LTD; WAX,BONE

Catalog Number 1503832

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).The reporter stated they have experienced the issue many times since (b)(6) 2014 (exact number and dates not provided).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient started re-bleeding within 1-2 hours after application of ostene.The patient was undergoing a sternotomy surgery.The site of application was not reported.It was reported that 20 minutes after the ostene was applied, the ostene started to dissolve.Additionally, it was reported that the dissolution occurred even faster while the cardiovascular surgeon was performing irrigation.It was reported that the product was not warmed to body temperature and further described as "the product was not warmed prior to use and it's condition wasn't different than usual".The amount of blood loss, medical intervention, and the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: WAX,BONE
• Manufacturer (Section D): BAXTER APATECH LTD; 370 centennial ave; hertfordshire ; UK
• Manufacturer (Section G): BAXTER APATECH LTD; 370 centennial ave; hertfordshire ; UK
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5071972
• MDR Text Key: 25584818
• Report Number: 1416980-2015-35706
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1503832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other