MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OSTENE; WAX, BONE

Catalog Number ASKU

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.

Event Description

A patient underwent an unspecified surgery in which osteone was used.It was reported it took ¿less than two hours to start bleeding again after use¿ with the product.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information, b5: upon follow up it was reported the patient did not require a transfusion.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OSTENE
• Type of Device: WAX, BONE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ELSTREE; 370 centennial avenue; elstree, borehamwood; hertfordshire WD6 3 TJ; UK WD6 3TJ
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13481102
• MDR Text Key: 285321708
• Report Number: 1416980-2022-00398
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/14/2022
• 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