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

Model Number NUS-106

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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
• Type of Device: SEALANT, DURAL
• Manufacturer (Section D): HYPERBRANCH MEDICAL TECHNOLOGY INC; durham NC 27713
• MDR Report Key: 15233557
• MDR Text Key: 298070435
• Report Number: MW5111481
• Device Sequence Number: 1
• Product Code: NQR
• UDI-Device Identifier: 00897146002018
• UDI-Public: (01)00897146002018(17)240531(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2022
• Patient Sequence Number: 1