MAUDE Adverse Event Report: HYPERBRANCH MEDICAL TECHNOLOGY INC ADHERUS AUTOSPRAY DURAL SEALANT; SEALANT, DURAL

Model Number	NUS-106
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Adheres autospray dural sealant malfunctioned and became stuck when trying to mix product resulting in only partial mixture and inability to use.Fda safety report id# (b)(4).

• Brand Name: ADHERUS AUTOSPRAY DURAL SEALANT
• Common Device Name: SEALANT, DURAL
• Manufacturer (Section D): HYPERBRANCH MEDICAL TECHNOLOGY INC; durham NC 27713
• MDR Report Key: 15233557
• Report Number: MW5111481
• Device Sequence Number: 6720779
• Product Code: NQR
• UDI-Device Identifier: 00897146002018
• UDI-Public: (01)00897146002018(17)240531(10)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: NUS-106
• Device Catalogue Number: NUS-106
• Device Lot Number: 05224039
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown