MAUDE Adverse Event Report: STRYKER CORP. (HYPERBRANCH MEDICAL TECHNOLOGY, INC.) ADHERUS AUTOSPRAY ET DURAL SEALANT; SEALANT, DURAL

Model Number NUS-109

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

Second issue with the stryker adherus - after the first one of these failed to turn on, the scrub and nurse opened a second one to try again, and the same result happened.After setting it all up, the device wouldn't turn on after multiple attempts of hitting the button to turn on.

• Brand Name: ADHERUS AUTOSPRAY ET DURAL SEALANT
• Type of Device: SEALANT, DURAL
• Manufacturer (Section D): STRYKER CORP. (HYPERBRANCH MEDICAL TECHNOLOGY, INC.); 800 capitola dr ste 12; durham NC 27713
• MDR Report Key: 9391764
• MDR Text Key: 168448894
• Report Number: 9391764
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2019

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: No Information
• Device Model Number: NUS-109
• Device Lot Number: 05192724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA