MAUDE Adverse Event Report: CP MEDICAL WAX, BONE; BONE WAX

Model Number BW25G

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hematoma (1884)

Event Date 05/17/2017

Event Type  Injury  

Event Description

During surgery, it was reported that the product had a bad texture and bad support in the bone with difficult use resulting to an absence of hemostatic effect.There was an appeared of a hematoma and another surgery had been necessary to resolve the case.

• Brand Name: WAX, BONE
• Type of Device: BONE WAX
• Manufacturer (Section D): CP MEDICAL; norcross GA 30093
• MDR Report Key: 7128153
• MDR Text Key: 95258218
• Report Number: MW5074094
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 10884521196261
• UDI-Public: 10884521196261
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Device Lot Number: 160414-58
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other