MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD®; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Patient in skull clamp for procedure.After md removed skull pins patient noted to have excessive blood on pillow.Md noted patient to have scalp laceration on right side of head.Patient head cleaned with h2o2 and nss, staples applied by md, dressing applied and patient sent to pacu.

• Brand Name: MAYFIELD®
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 15635753
• MDR Text Key: 302065714
• Report Number: 15635753
• Device Sequence Number: 1
• Product Code: HBL
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21535 DA
• Patient Sex: Female