MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF CODMAN DISPOSABLE PERFORATOR; CRANIAL PERFORATOR

Model Number 26-1221

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Eye Injury (1845); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Blurred Vision (2137)

Event Date 12/13/2016

Event Type  malfunction  

Event Description

Codman disposable perforator 14mm (lotjj011s) malfunctioned while in use by physician attending.Item removed from sterile field and was saved to be given to codman rep.Codman rep notified.A (b)(6), presented to ed with 2 days ha, and pain behind right eye, blurred vision, b/p elevated, head ct shown acute parenchymal hemorrhage, taken to operating room for craniotomy to evacuate hematoma.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: CRANIAL PERFORATOR
• Manufacturer (Section D): JOHNSON AND JOHNSON/ CODMAN AND SHURTLEFF; new brunswick NJ 08933
• MDR Report Key: 6193330
• MDR Text Key: 63133709
• Report Number: MW5066823
• Device Sequence Number: 1
• Product Code: KAT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 26-1221
• Device Lot Number: JJO13S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 99