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

Model Number	BW25G
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BONE WAX
• Manufacturer (Section D): CP MEDICAL; norcross GA 30093
• MDR Report Key: 7128153
• Report Number: MW5074094
• Device Sequence Number: 13903017
• Product Code: MTJ
• UDI-Device Identifier: 10884521196261
• UDI-Public: 10884521196261
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Device Lot Number: 160414-58
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other