MAUDE Adverse Event Report: HANS BIOMED VIVEX DBM PLUS; BONE VIOD FILLER

Model Number VX-EP5

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Nausea (1970); Pain (1994); Swelling (2091); Loss of consciousness (2418)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient complained of swelling and pain in her leg.Patient was home when she felt nausea feverish and passed out at home.Surgeon looked at her immediately, same day surgery; drainage, treated for post-op infection, graft was not removed; incision made arthroscopic; gram scan; biopsy performed.Patient is now healing in rehab.

• Brand Name: VIVEX DBM PLUS
• Type of Device: BONE VIOD FILLER
• Manufacturer (Section D): HANS BIOMED; 64, yuseong-daero 1628beon-gil; yuseong-gu; daejeon, 34054 ; KS 34054
• Manufacturer (Section G): HANS BIOMED CORP.; 64, yuseong-daero 1628beon-gil; yuseong-gu; daejeon, 34054 ; KS 34054
• Manufacturer Contact: lucy choi ; 64 yuseong-daero 1628beon-gil; yuseong-gu; daejoen, 34054 ; KS 34054
• MDR Report Key: 7262330
• MDR Text Key: 100052403
• Report Number: 3003828812-2018-00001
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 08809204339235
• UDI-Public: (01)08809204339235(17)180118(01)08809204339235(17)180118(21)Q16010U-058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 01/18/2018
• Device Model Number: VX-EP5
• Device Lot Number: Q16011U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 72